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Drugs

Updated: May 6, 2022 6:19 AM
I ordered a sex performance booster online, it was recalled due to adverse effects. I had a stroke later the same day. It is "MegMen performance booster ". Im in Nashville, the company that sold me the recalled over the counter drug is in New York. According... See More I need help finding a lawyer to help me? See Less
860


St. Paul, Minnesota, Fagron Inc. (“Fagron”) is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. The affected lots are potentially contaminated with Burkholderia gladioli.

Burkholderia gladioli is an opportunistic pathogen most commonly affecting patients... See More with respiratory disease. Patients with compromised immune systems such as those with Cystic Fibrosis are at higher risk. Burkholderia gladioli also can cause complications after transplants. Exposure to contaminated product could lead to adverse events, which could be severe for at-risk individuals.

Fagron has received three complaints regarding an undesirable smell associated with the product. To date, Fagron has not received any reports of adverse events related to the product being recalled. Fagron sells this product for the extemporaneous compounding of prescriptions for oral dosing. The affected lots with expiration dates are listed below.

Affected products:
Lot: A67185
Item number: 805359
Size: 500 mL
NDC number: 51552-1123-5
Expiration date: 08/31/2024

Lot: A67186
Item number: 802496
Size: 4 L
NDC number:51551-1123-9
Expiration date: 08/31/2024

Fagron has already notified its distributors and customers by phone, e-mail, and/or letter and is arranging for return of all recalled products. Hospitals, pharmacies, and distributors that possess affected product should quarantine this material and await further instructions from Fagron or Fagron’s recall coordinator. Please immediately discontinue use or distribution of the recalled product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Fagron Inc.
Brand name: Fagron
Product recalled: SyrSpend SF 500mL and 4L
Reason of the recall: Potential contamination with Burkholderia gladioli
FDA Recall date: May 02, 2022

Source: fda.gov
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413


Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.

Nitrosamines are common in water and foods, including... See More cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.i Accupril is indicated for the treatment of hypertension, to lower blood pressure. 

Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. Accupril has a safety profile that has been established over 30 years. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. Accupril® (Quinapril HCl Tablets), 10 mgAccupril® (Quinapril HCl Tablets), 20 mgAccupril® (Quinapril HCl Tablets), 40 mg.

NDC: 0071-0530-23
Lot Number: DR9639
Expiration Date: 2023 MAR 31
Strength: 10 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0532-23
Lot Number: DX8682
Expiration Date: 2023 MAR 31
Strength: 20 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0532-23
Lot Number: DG1188
Expiration Date: 2022 MAY 31
Strength: 20 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0535-23
Lot Number: DX6031
Expiration Date: 2023 MAR 31
Strength: 40 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0535-23
Lot Number: CK6260
Expiration Date: 2022 MAY 31
Strength: 40 mg
Configuration/ Count: 1 x 90 count bottle

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you.

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Sedgwick. Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product.

Company name: Pfizer
Brand name: Pfizer
Product recalled: Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg
Reason of the recall: Due to N-Nitroso-Quinapril Content
FDA Recall date: April 22, 2022

Source: fda.gov
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414


Boil Water Alerts for Businesses
Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine- yfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This product is not the branded Semglee vial but the unbranded Insulin... See More Glargine- yfgn vial. This batch is being recalled due to the potential for the label to be missing on some vials.

The product information, batch number and expiry date information are present on the carton. This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between December 9, 2021, and March 4, 2022. The recalled batch is as follows:

NDC # 49502-393-80
Name and Strength: Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100)
Size: 10 mL vial
Batch# BF21002800
Expiry: Aug 2023

Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

This recall does not pertain to the branded interchangeable biosimilar, Semglee® (insulin glargine-yfgn) injection but to the unbranded interchangeable biosimilar Insulin Glargine-yfgn vial.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Mylan Pharmaceuticals, Inc. a Viatris Company
Brand name: Mylan
Product recalled: Insulin Glargine (Insulin glargine-yfgn) Injection
Reason of the recall: Label may be missing on some vials
FDA Recall date: April 12, 2022

Source: fda.gov
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414


Teva Pharmaceuticals has initiated a voluntary nationwide recall of lot 31329657B of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial, to the user level in the United States. This voluntary recall is initiated based on an internal inspection that found particulate matter in one vial of the... See More product identified as silica and iron oxide. No other vials have been observed to contain this defect.

To date, Teva has received no product quality complaints or adverse event reports of this nature for the subject recall lot.

The administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. While the health hazard risk could be severe if particulate matter is infused, Teva’s internal health assessment determined that the likelihood of patient harm is remote or unlikely IDArubicin Hydrochloride Injection USP in combination with other approved anti-leukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults.

Information about the affected product is listed in below. It is packed in 5 mL Single Dose Vials. Teva distributed 1,565 vials Nationwide from 12-04-2020 through 08-18-2021 to 4 of its Wholesale customers under the label for Teva Pharmaceuticals USA, Inc.

- Recalled product:

Vial/Carton NDC: 0703-4154-11
Lot # 31329657B
Exp. Date 08/2023

Any consumer who has questions or concerns should first consult with their health care provider(s). This recall was made with the knowledge of the Food and Drug Administration.

Company name: Teva Pharmaceuticals
Brand name: Teva Pharmaceuticals
Product recalled: IDArubicin Hydrochloride Injection USP
Reason of the recall: Potential Particulate Matter (silica and iron oxide)
FDA Recall date: March 29, 2022

Source: fda.gov
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413


Plastikon Healthcare, LLC is voluntarily recalling three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one (1) lot of Acetaminophen 650mg/ 20.3mL, and six (6) lots of Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL to the hospital, clinic and patient level. The... See More products are being recalled due to microbial contamination and failure to properly investigate failed microbial testing. The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler) between 5/1/2020 and 6/28/2021, who shipped to hospitals, nursing homes, and clinics nationwide. 

This product potentially could result in illness due to intestinal distress, such as diarrhea or abdominal pain.  Individuals with a compromised immune system have a higher probability of developing a wide-spread, potentially life-threatening infection when ingesting or otherwise orally exposed to products contaminated by micro-organisms.

To date, Plastikon has not received any customer complaints related to microbial concerns or reports of adverse events related to this recall. Product indication, lot numbers, expiration dates and NDC information are listed below. The product is packaged for institutional use and is sold to clinics and hospitals nationwide in single use cups with a foil lid. The products are private labeled for Major Pharmaceuticals.

Recalled products:

- Product Name: Milk of Magnesia 2400 mg/30 mL Oral Suspension
Indications for use: Milk of Magnesia 2400 mg/ 30 mL is indicated for the occasional relief of constipation
(irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor.
Lot/exp.
20024A/Mar 2022
20025A/Mar 2022
20041A/May 2022
NDC: 0904-6846-73
Type of Packaging: Carton containing 100 single dose cups (10 trays x 10 cups)

- Product name: Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/ Simethicone 120mg per 30 mL
Indications for use: Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL is indicated for relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure and bloating commonly referred to as gas.
Lot/exp.
20042A/May 2022
20043A/May 2022
20045A/May 2022
20046A/May 2022
20047A/May 2022
21067A/Jun 2023
NDC: 0904-6838-73
Type of Packaging: Carton containing 100 single dose cups (10 trays x 10 cups)

- Product name: Acetaminophen 650mg/ 20.3mL
Indications for use: Acetaminophen 650mg/ 20.3mL indicated for temporarily relief of minor aches and pains due to, minor pain of arthritis, muscular aches, backache, premenstrual and menstrual cramps, the common cold, headache, toothache, and temporarily reduction of fever.
Lot/exp. 20040A/May 2022
NDC: 0904-6820-76
Type of Packaging: Carton containing 100 single dose cups (10 trays x 10 cups)

Plastikon Healthcare places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Plastikon Healthcare has notified its direct customers via a recall letter to arrange for return of any recalled product. Anyone with an existing inventory of the lots which are being recalled should stop use and distribution, and quarantine immediately. Return all quarantined product to the place of purchase. For clinics, hospitals, or healthcare providers that have dispensed product to patients, please notify patients regarding the recall.

Patients are advised to contact their doctor or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Company name: Plastikon Healthcare, LLC
Brand name: Major Pharmaceuticals
Product recalled: Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mL
Reason of the recall: Microbial Contamination
FDA Recall date: March 24, 2022

Source: fda.gov
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Reckitt has announced a recall of its Airborne Gummies (63 and 75 count bottles) sold in blueberry pomegranate, orange and assorted fruit flavors due to injury hazard, when opened for the first time, pressure build up in the bottle can cause the cap and underlying seal to... See More pop off with force. These products were distributed in Target, Walgreens, CVS, Kroger, Sam’s Club, BJ’s Wholesale Club, Costco, Walmart and other stores nationwide in the USA and online at Amazon.com and www.schiffvitamins.com from May 2020 through February 2022.

The following UPC numbers and lot codes located on the bottom of the bottle are included in this recall.

UPC and Lot Codes for 63-count gummies:

- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC1270G. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 11/30/2021.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC1400A. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 11/30/2021.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC1400B. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 11/30/2021.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC1900H. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 3/31/2022.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC2180C. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 4/30/2022.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC2320A. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 4/30/2022.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC3080A. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 7/31/2022.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC3300A. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 7/31/2022.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC3300B. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 7/31/2022.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC3080E. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 7/31/2022.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC3440B. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 8/31/2022.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC3440C. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 8/31/2022.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC3440J. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 8/31/2022.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC3440K. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 8/31/2022.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC0301H. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 9/30/2022.
- 12-digit UPC /SKU: 6-47865-96299-1. Lot Code: AC0301A. Description: Airborne Gummies - Assorted Fruit 63 ct. Expiration: 9/30/2022.
- 12-digit UPC /SKU: 6-47865-96339-4. Lot Code: AC1350B. Description: Airborne Gummies - Orange 63 ct. Expiration: 1/31/2022.
- 12-digit UPC /SKU: 6-47865-96339-4. Lot Code: AC1690B. Description: Airborne Gummies - Orange 63 ct. Expiration: 2/28/2022.
- 12-digit UPC /SKU: 6-47865-96339-4. Lot Code: AC1690D. Description: Airborne Gummies - Orange 63 ct. Expiration: 2/28/2022.
- 12-digit UPC /SKU: 6-47865-96339-4. Lot Code: AC2030A. Description: Airborne Gummies - Orange 63 ct. Expiration: 3/31/2022.
- 12-digit UPC /SKU: 6-47865-96339-4. Lot Code: AC1690C. Description: Airborne Gummies - Orange 63 ct. Expiration: 2/28/2022.
- 12-digit UPC /SKU: 6-47865-96339-4. Lot Code: AC2570A. Description: Airborne Gummies - Orange 63 ct. Expiration: 5/31/2022.
- 12-digit UPC /SKU: 6-47865-96339-4. Lot Code: AC3140D. Description: Airborne Gummies - Orange 63 ct. Expiration: 6/30/2022.
- 12-digit UPC /SKU: 6-47865-96339-4. Lot Code: AC2850D. Description: Airborne Gummies - Orange 63 ct. Expiration: 6/30/2022.
- 12-digit UPC /SKU: 6-47865-96339-4. Lot Code: AC2850E. Description: Airborne Gummies - Orange 63 ct. Expiration: 6/30/2022.
- 12-digit UPC /SKU: 6-47865-99557-9. Lot Code: AC1620B. Description: Airborne Gummies - Kids 63 ct. Expiration: 12/31/2021.
- 12-digit UPC /SKU: 6-47865-99557-9. Lot Code: AC1330D. Description: Airborne Gummies - Kids 63 ct. Expiration: 11/30/2021.
- 12-digit UPC /SKU: 6-47865-99557-9. Lot Code: AC1620A. Description: Airborne Gummies - Kids 63 ct. Expiration: 12/31/2021.
- 12-digit UPC /SKU: 6-47865-99557-9. Lot Code: AC1790C. Description: Airborne Gummies - Kids 63 ct. Expiration: 2/28/2022.
- 12-digit UPC /SKU: 6-47865-99557-9. Lot Code: AC0661B. Description: Airborne Gummies - Kids 63 ct. Expiration: 11/30/2022.
- 12-digit UPC /SKU: 6-47865-99557-9. Lot Code: AC0661C. Description: Airborne Gummies - Kids 63 ct. Expiration: 11/30/2022.
- 12-digit UPC /SKU: 6-47865-99601-9. Lot Code: AC1041A. Description: Airborne Gummies - Blueberry Pomegranate 63 ct. Expiration: 12/31/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC1270G. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 11/30/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC1400A. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 11/30/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC1400B. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 11/30/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC1900H. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 3/31/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC2180C. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 4/30/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC2320A. Description: Airborne Gummies - Assorted Fruit (2x63) ct. Expiration: 4/30/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC3080A. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 7/31/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC3300A. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 7/31/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC3300B. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 7/31/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC3080E. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 7/31/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC3440B. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 44804.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC3440C. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 8/31/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC3440J. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 8/31/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC3440K. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 8/31/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC0301H. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 9/30/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC0301A. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 9/30/2022.
- 12-digit UPC /SKU: 6-47865-99564-7. Lot Code: AC0301A. Description: Airborne Gummies - Assorted Fruit Bundle Pack (2x63) ct. Expiration: 9/30/2022.

UPC and Lot Codes for 75-count gummies:

- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC1140G. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 10/31/2021.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC1140H. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 10/31/2021.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC1140I. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 10/31/2021.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC1270D. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 11/30/2021.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC1640A. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 12/31/2021.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC1640B. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 12/31/2021.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC1780G. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 2/28/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC2060F. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 3/31/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC2060G. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 3/31/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC2180A. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 4/30/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC2180B. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 4/30/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC2180D. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 4/30/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC2180E. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 4/30/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC2320B. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 4/30/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC2320C. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 4/30/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC2770G. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 6/30/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC2770J. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 6/30/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC2560F. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 5/31/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC3080B. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 7/31/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC3080C. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 7/31/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC3080D. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 7/31/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC2560J. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 5/31/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC3440A. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 8/31/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC0441B. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 10/31/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC0441D. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 10/31/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC0301I. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 9/30/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC0691B. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 11/30/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC0691C. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 11/30/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC1051A. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 12/31/2022.
- 12-digit UPC /SKU: 6 47865 18574 1. Lot Code: AC1580E. Description: Airborne Gummies - Assorted Fruit 75 ct. Expiration: 2/2/2022.
- 12-digit UPC /SKU: 6 47865 90530 1. Lot Code: AC2040D. Description: Airborne Gummies Kids - Assorted Fruit 75 ct. Expiration: 3/31/2022.
- 12-digit UPC /SKU: 6 47865 90530 1. Lot Code: AC3020B. Description: Airborne Gummies Kids - Assorted Fruit 75 ct. Expiration: 6/30/2022.
- 12-digit UPC /SKU: 6 47865 90530 1. Lot Code: AC0661D. Description: Airborne Gummies Kids - Assorted Fruit 75 ct. Expiration: 11/30/2022.

Reckitt has received 70 reports of the cap or seal popping off the bottles, including 18 reports of minor injuries and one report of an eye injury requiring medical attention.

Consumers with an unopened bottle(s) should not attempt to open the product and should contact Reckitt to return the unopened bottle(s) to receive a full refund. A postage-paid label will be provided. Bottles that have already been opened are not subject to this recall as they would have released any pressure build up and do not present an injury hazard.

Source: cpsc.gov
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Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level.... See More To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. 

Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

These products are indicated for the treatment of hypertension.  Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor about alternative treatment options.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables in the link below and photos of the products can be found below. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from November 2019 to March 2022.

- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mg
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mg
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mg
- quinapril and hydrochlorothiazide tablets, 20/25 mg
- quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
- quinapril HCl/hydrochlorothiazide tablets, 20/25 mg

Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you.

Company name: Pfizer
Brand name: Accuretic, Greenstone Brand
Product recalled: Accuretic™ (quinapril HCl/hydrochlorothiazide); quinapril and hydrochlorothiazide; and quinapril HCl/hydrochlorothiazide tablets
Reason of the recall: Presence of a nitrosamine, N-nitroso-quinapril
FDA Recall date: March 22, 2022

Source: fda.gov
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Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) is voluntarily recalling certain lots of SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes to the consumer level. The batches in the table below are being recalled due to the potential clogging of... See More the needle preventing the dispensing of epinephrine. US WorldMeds (USWM) exclusively markets and distributes SYMJEPI in the United States, under license from Adamis, the NDA holder.

USWM will handle the entire recall process for Adamis, with Adamis oversight. SYMJEPI is manufactured and tested for Adamis by Catalent Belgium S.A. Risk Statement: If a person is experiencing an allergic reaction and/or anaphylaxis and is unable to access life-saving epinephrine due to the syringe malfunction, it can lead to life threatening consequences including death. Although not confirmed to be related to the recall, there have been two different customer complaints on three syringes, regarding difficulty in dispensing the product, to date.

However, neither US WorldMeds nor Adamis Pharmaceuticals has received, or is aware of, any adverse events related to this recall. The recall encompasses all of the following batches, within expiry:

+ SYMJEPI (epinephrine) Injection.
-- Strength: 0.15 mg/0.3 mL. NDC: 78670-131-02. Lot: 21101Y. Expiration: 11/30/2022
-- Strength: 0.3 mg/0.3 mL. NDC: 78670-130-02. Lot | Expiration: 21041W | 8/31/2022. 21081W | 11/30/2022. 21102W | 2/28/2023

SYMJEPI is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets, and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

The products are packaged in 2-count Pre-Filled Single-Dose Syringes per carton and were distributed nationwide in the USA and directly to customers and/or medical facilities. The products can be identified by the label containing the US WorldMeds name and logo pictured on the cartons below.

Company name: Adamis Pharmaceuticals Corporation
Brand name: Adamis Pharmaceuticals Corporation
Product recalled: SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes
Reason of the recall: Potential clogging of the needle preventing the dispensing of epinephrine
FDA Recall date: March 22, 2022

Source: fda.gov
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Sandoz Inc. (“Sandoz”) is initiating a voluntary recall of 13 lots (listed below) of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level. The presence of a nitrosamine (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine (NMOA or Nitroso-Orphenadrine)) impurity, which has the potential to be above the U.S. Food... See More and Drug Administration (FDA)’s Acceptable Daily Intake (ADI) limit of 26.5 ng/day, was detected in the lots during recent testing.

These 13 lots of Orphenadrine Citrate ER Tablets were shipped to customers from August 2019 to April 2021. Nitrosamines are substances with carcinogenic potency (substances that could cause cancer) when present above the allowable exposure limits. While the use of product belonging to the recalled lots may represent a risk to patients, to date, Sandoz has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.

Orphenadrine Citrate ER Tablets are used as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The product is packaged in 100-count and 1000-count bottles and was distributed nationwide in the USA to wholesalers and distributors.

- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: JX6411. Expiration Date: May 22. Date of Manufacture: 5/24/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: JX6413. Expiration Date: May-22. Date of Manufacture: 5/24/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KC0723. Expiration Date: Aug-22. Date of Manufacture: 8/21/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KC3303. Expiration Date: Aug-22. Date of Manufacture: 8/21/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KE4348. Expiration Date: Nov-22. Date of Manufacture: 11/6/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KE7169. Expiration Date: Nov-22. Date of Manufacture: 11/6/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KE4349. Expiration Date: Nov-22. Date of Manufacture: 11/6/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KL3199. Expiration Date: Mar-23. Date of Manufacture: 3/3/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KM0072. Expiration Date: Mar-23. Date of Manufacture: 3/3/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0815-022-10. Lot Number: KS3939+. Expiration Date: Mar-23. Date of Manufacture: 3/3/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: LA7704. Expiration Date: Oct-23. Date of Manufacture: 10/6/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: LA7703. Expiration Date: Oct-23. Date of Manufacture: 10/6/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: LA9243. Expiration Date: Oct-23. Date of Manufacture: 11/18/2020

This recall of Orphenadrine Citrate ER Tablets is specific to the lots listed above and does not apply to any other strengths of Sandoz Orphenadrine Citrate ER Tablets nor to other lot numbers of the product. Any product returned that is not associated with this recall will be destroyed, and no credit will be issued.

Sandoz is notifying its wholesalers and distributors by mail and is arranging for the return of all recalled product. Wholesalers and distributors that have Orphenadrine Citrate ER Tablets subject to this recall should immediately stop distribution of the recalled product and quarantine and return all recalled product in their inventory.

Consumers who have Orphenadrine Citrate ER Tablets being recalled should stop taking the recalled product and immediately consult with their physician to obtain another prescription.

Company name: Sandoz, Inc.
Brand name: Sandoz
Product recalled: Orphenadrine Citrate 100 mg Extended Release (ER) Tablets
Reason of the recall: Presence of a Nitrosamine Impurity
FDA Recall date: March 22, 2022

Source: fda.gov
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