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Recall

Updated: November 24, 2022 5:22 PM
The Arizona Department of Health Services (ADHS) announced the recall of specific marijuana products cultivated by PP Wellness due to possible contamination with Aspergillus, a fungus that can cause allergic reactions or infection, usually in people already sick with something else. These products were sold at multiple... See More locations with the product names listed below. To date, no illnesses have been reported.

The recalled products are:
Cultivator / Product Name / Batch Number / Product Type / Implicated Contaminant
- PP Wellness / El Alquimista / GH401 / Plant, Trim / Aspergillus
- PP Wellness / Tangie Head /GH403 / Plant, Trim / Aspergillus
- PP Wellness / Nasty Girl /GH404 / Plant, Trim / Aspergillus
- PP Wellness / The Juice / GH408/ Plant, Trim / Aspergillus
- PP Wellness / Gorilla Grapevine / GH413/ Plant, Trim / Aspergillus
- PP Wellness / The Juice / GH416 / Plant, Trim / Aspergillus

This announcement is being made out of an abundance of caution. Patients who have purchased potentially contaminated products should not ingest, inhale, or otherwise consume them and should dispose of them. Once ADHS discovered the positive test results, the establishment involved took immediate action to work with all distribution and retail partners to remove any potentially impacted products.

Aspergillus can cause allergic reactions or infections, usually in people already sick with something else. Symptoms range from asthma or cold-like symptoms to fever and chest pain among many others.

In case you experience harm from products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: azdhs.gov
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Mason Vitamins Inc. has issued a nationwide voluntary recall of the specific lot of Healthy Sense Daily Multiple with Iron and People’s Choice Women's Daily Vitamins with Iron due to Vitamin A, Vitamin B12, Vitamin C, Vitamin E and Pantothenic Acid amounts being lower than the declared... See More amount on the label which was determined during an FDA inspection. The products were sold nationwide at Bargain Barn, 99 Cents Only, Fruth Pharmacy, Joe V’s Smart Shop, Rose’s Discount Stores, Rex Discount Pharmacy, Star Discount Pharmacy, Propst Discount Pharmacy, Dollar Tree and limited distributors. To date, no illnesses related to these products have been reported.

Product Name: Healthy Sense Daily Multiple with Iron, Size: 20 tablets, UPC Code: 311845353238, Lot/Expiration Date: 25807G / 09/2024
Product Name: People’s Choice Women’s Daily Vitamins with Iron, Size: 30 tablets, UPC Code: 311845486882, Lot/Expiration Date: 25807G / 09/2024; A25807G / 09/2024; B25807G / 09/2024;C25807G / 09/2024; D25807G / 09/2024

No other People’s Choice and Healthy Sense products are affected by this recall. If customers have product affected by this voluntary recall, they should discard it immediately.

In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Mason Vitamins Inc.
Brand name: Healthy Sense and People’s Choice
Product recalled: Daily multi vitamin with Iron and Women’s daily vitamin with iron
Reason of the recall: Due to Vitamin 1, B12, C, E and Pantothenic Acid being lower than declared
FDA Recall date: November 17, 2022

Source: fda.gov
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Holland & Barrett is recalling soya lecithin soft gel capsules because they contain peanuts which are not mentioned on the label. This means the product is a possible health risk for anyone with an allergy to peanuts.

The recalled products are:
- Ultra Soya Lecithin 1200mg (50... See More capsules)
- Ultra Soya Lecithin 1200mg (100 capsules)
- Ultra Soya Lecithin 1200mg (250 capsules)
- Mega Soya Lecithin 1325 mg (100 capsules)

Company name: Holland & Barrett
Product recalled: Ultra Soya Lecithin 1200mg, Ultra Soya Lecithin 1200mg, Ultra Soya Lecithin 1200mg, Mega Soya Lecithin 1325 mg
FSA Recall date: 11/07/2022

If you have bought the recalled products and have an allergy to peanuts, do not eat them. Instead return them to the store from where they were bought for a full refund.

In case you experienced harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: food.gov.uk
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Thornton, Colorado, Adam’s Polishes, LLC is voluntarily recalling lot 133475 of Adam’s Polishes Hand Sanitizer to the consumer level. FDA testing has found this lot to contain undeclared methanol. Adam’s Polishes is recalling 19 other lots in an abundance of caution. The hand sanitizer was distributed nationwide... See More in the USA to internet customers between June 2020 and March 2022. To date, Adam’s Polishes has not received any reports of injury, illness, or other adverse events related to this recall.

Risk Statement: Persons who accidently ingest (drink) these products are at risk for methanol poisoning. Substantial methanol ingestion can result in coma, seizures, permanent blindness, permanent damage to the central nervous system, or death. This product is used as a hand sanitizer marketed to help decrease bacteria on the skin when soap and water are not available.

Adam’s Polishes Hand Sanitizer is packaged in 4oz., 8oz. 16oz., and one gallon bottles. These bottles are spray bottles for the 4oz, 8oz and 16oz and jugs for the gallon bottles. Lot numbers: 133470, 133471, 133472, 133473, 133474, 133475, 133476, 133477, 133478, 133479, 133480, 133481, 133482, 133483, 137731, 137732, 137733, 137734, 139322, 143327

Consumers who have any recalled Adam’s Polishes Hand Sanitizer products should immediately stop using the product and dispose of it in accordance with local regulations.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Adam’s Polishes, LLC
Brand name: Adam’s Polishes
Product recalled: Hand sanitizer
Reason of the recall: Presence of methanol
FDA Recall date: November 07, 2022

Source: fda.gov
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Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), announced on October 17, 2022, a Medical Device Correction for all Omnipod DASH® Personal Diabetes Managers (PDMs) distributed globally. This action was taken voluntarily with the knowledge of the FDA and other regulatory agencies. Insulet received reports from Omnipod... See More DASH users regarding PDM battery issues, including battery swelling and leakage, and in rare cases, extreme overheating, which has resulted in reports of fire.

The Company’s investigation determined that the Omnipod DASH PDM is at increased risk of malfunction if overcharged beyond the maximum battery voltage, which could potentially lead to serious injury or death. There have been 50 complaints about this issue. No serious injuries or deaths have been reported as a result of this potential issue. As previously communicated to Omnipod DASH users, Insulet has identified an update to the Omnipod DASH PDM that will resolve this issue.

The Company expects to begin shipping updated Omnipod DASH PDMs to all current Omnipod DASH customers in the coming months. All affected Omnipod DASH consumers are being notified by email and local mail. Insulet has been providing customers with instructions to help reduce the risk of PDM battery issues.

This Medical Device Correction does not affect Omnipod DASH Pods, the Omnipod® Insulin Management System, or the Omnipod® 5 Automated Insulin Delivery System.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Insulet Corporation
Brand name: Insulet Corporation Omnipod DASH
Product recalled: Personal Diabetes Managers
Reason of the recall: Battery issue: battery swelling, leakage, and in rare cases, extreme overheating, which has resulted in reports of fire.
FDA Recall date: November 05, 2022

Source: fda.gov
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Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of affected lots of the below-referenced Gibeck® Iso-Gard® Filter products. The Gibeck® Iso-Gard® Filter is a bacterial and viral filter, intended for connection to respiratory equipment... See More in intensive care units and operating theatres to protect the equipment from potential airborne contaminants. If the filter splits or detaches during use, the functionality and efficiency of the device may be compromised, potentially resulting in a leakage and insufficient air supply to the patient with potential desaturation.

The products involved in the recall are listed below. Additional detail about how to identify the affected products is available in the recall letter.

Product Codes: 19012. Commercial Name: Iso-Gard® Filter S with Expandi-Flex/Elbow

Product Codes: 19012T. Commercial Name: Iso-Gard® Filter S with Expandi-Flex/Elbow, Tethered Cap

Product Codes: 191667-000100. Commercial Name: Filter + Catheter Mount

Product Codes: 19211; 19212. Commercial Name: Iso-Gard® Filter S

Product Codes: 19261; 19272. Commercial Name: Iso-Gard® Filter S with Expandi-Flex

Product Codes: 19261T; 19262T; 19272T. Commercial Name: Iso-Gard® Filter S with Expandi-Flex, Tethered Cap

Product Codes: 19211T; 19212T. Commercial Name: Iso-Gard® Filter S, Tethered Cap

Note: This recall is for specific lots of the above-referenced product codes.

In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Teleflex Incorporated
Brand name: Gibeck® and Iso-Gard®
Product recalled: Bacterial and viral filters
Reason of the recall: Bacterial and viral filters
FDA Recall date: November 04, 2022

Source: fda.gov
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Whele LLC, of Boston, MA, is voluntarily recalling its Mighty Bliss Electric Heating Pad, due to product safety concerns. Use of this product may lead to burns, mild shocks, or rashes/irritation. Product was sold via Amazon.com and Walmart.com. We received 286 complaints between July 2021 to September... See More 2022 related to the product overheating, sparking, burning, or presenting other electrical problems. 31 of these complaints reported injuries such as mild shocks, burns, and rashes or irritation.

This recall applies to 544,212 Mighty Bliss Electric Heating Pad units manufactured between 08JAN21 to 03JAN22 and distributed from 29JUL21 through 21JUL22. Model Numbers and Descriptions Below:
- MB-001 (NA-H1121B): Large (12” x 24”) Blue Electric Heating Pad
- MB-002 (NA-H21C): Extra-Large (20” x 24”) Blue Electric Heating Pad
- PE-MtyBls-HeatPad-12x24-Gry-V2(NA-H1121B): Large (12” x 24”) Grey Electric Heating Pad

The product lot number can be found directly on the heating pad listed in black text beneath the product instructions.

Company name: Whele LLC
Brand name: Mighty Bliss
Product recalled: Heating pads
Reason of the recall: Use of product may lead to burns, mild shocks, or rashes and irritation
FDA Recall date: October 24, 2022

This recall has been initiated due to product safety concerns. Use of this product may lead to electric shocks and/or skin irritation, rashes, blisters, or burns. Severe burns may result in infection or formation of scar tissue.

Customer/User Immediately cease use of the product. Distributor Immediately examine your inventory and quarantine the product subject to recall. We will be in contact to gather any remaining inventory for destruction. If you may have further distributed this product, please identify your customers and notify them within two (2) business days of this product recall.

Source: fda.gov
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Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20count carton, to the consumer level. Product was distributed nationwide to wholesalers, distributors, and other customers between December 16, 2021 and August 10, 2022.

Risk Statement: The... See More product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failures.

The product is used for treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Image 1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, Image 2).

The affected Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:

- Brand (Exela). Lot: P0001370. Expire Date: 10/23.
- Brand (Exela). Lot: P0001371. Expire Date: 10/24.
- Brand (Exela). Lot: P0001372. Expire Date: 10/23.
- Brand (Exela). Lot: P0001433. Expire Date: 11/23.
- Brand (Exela). Lot: P0001434. Expire Date: 11/23.
- Brand (Exela). Lot: P0001443. Expire Date: 12/23.
- Brand (Exela). Lot: P0001468. Expire Date: 12/23.
- Brand (Exela). Lot: P0001469. Expire Date: 12/23.
- Brand (Exela). Lot: P0001470. Expire Date: 12/23.
- Brand (Exela). Lot: P0001495. Expire Date: 12/23.
- Brand (Exela). Lot: P0001505. Expire Date: 12/23.
- Brand (Exela). Lot: P0001506. Expire Date: 12/23.
- Brand (Exela). Lot: P0001509. Expire Date: 12/23.
- Brand (Exela). Lot: P0001510. Expire Date: 12/23.
- Brand (Exela). Lot: P0001511. Expire Date: 12/23.
- Brand (Exela). Lot: P0001512. Expire Date: 12/23.
- Brand (Exela). Lot: P0001560. Expire Date: 01/24.
- Brand (Exela). Lot: P0001561. Expire Date: 01/24.
- Brand (Exela). Lot: P0001562. Expire Date: 01/24.
- Brand (Exela). Lot: P0001564. Expire Date: 01/24.
- Brand (Exela). Lot: P0001566. Expire Date: 01/24.
- Brand (Exela). Lot: P0001567. Expire Date: 01/24.
- Brand (Exela). Lot: P0001568. Expire Date: 01/24.
- Brand (Exela). Lot: P0001571. Expire Date: 02/24.
- Brand (Exela). Lot: P0001572. Expire Date: 02/24.
- Brand (Exela). Lot: P0001573. Expire Date: 02/24.
- Brand (Exela). Lot: P0001574. Expire Date: 02/24.
- Brand (Exela). Lot: P0001578. Expire Date: 02/24.
- Brand (Exela). Lot: P0001579. Expire Date: 02/24.
- Brand (Exela). Lot: P0001580. Expire Date: 02/24.
- Brand (Exela). Lot: P0001583. Expire Date: 02/24.
- Brand (Exela). Lot: P0001586. Expire Date: 02/24.
- Brand (Exela). Lot: P0001587. Expire Date: 02/24.
- Brand (Exela). Lot: P0001588. Expire Date: 02/24.
- Brand (Exela). Lot: P0001593. Expire Date: 02/24.
- Brand (Exela). Lot: P0001594. Expire Date: 02/24.
- Brand (Exela). Lot: P0001610. Expire Date: 02/24.
- Brand (Exela). Lot: P0001618. Expire Date: 02/24.
- Brand (Exela). Lot: P0001619. Expire Date: 02/24.
- Brand (Exela). Lot: P0001644. Expire Date: 03/24.
- Brand (Exela). Lot: P0001645. Expire Date: 03/24.
- Brand (Exela). Lot: P0001646. Expire Date: 03/24.
- Brand (Exela). Lot: P0001654. Expire Date: 02/24.
- Brand (Exela). Lot: P0001662. Expire Date: 03/24.
- Brand (Exela). Lot: P0001664. Expire Date: 03/24.
- Brand (Exela). Lot: P0001730. Expire Date: 05/24.
- Brand (Civica). Lot: P0001497. Expire Date: 12/23.
- Brand (Civica). Lot: P0001600. Expire Date: 02/24.
- Brand (Civica). Lot: P0001663. Expire Date: 03/24.

The Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) can be identified by the NDC numbers, and by the yellow flip-top safety cap on the 50 mL vial. The carton bears a purple stripe containing concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner. The vial label bears a purple stripe containing concentration information with the name “Exela Pharma Sciences” on the back.

The Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) can be identified by the NDC numbers, by the yellow flip-top safety cap on the 50 mL vial, and by the carton which bears a green stripe containing concentration information and the manufacturer name “Civica” in the lower right-hand corner. The vial label bears a green stripe containing concentration information with the name “Civica” on the back.

All the above-listed lots are supplied in 20 count cartons only. This recall is not expected to cause drug shortage.

Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela.

In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Exela Pharma Sciences, LLC
Brand name: Exela & Civica
Product recalled: Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial
Reason of the recall: Vial Breakage
FDA Recall date: October 13, 2022

Source: fda.gov
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Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This voluntary... See More recall only affects products with lot# GS046745. No other Clopidogrel or Atenolol products marketed by GSMS, Inc. are impacted. Both products are being recalled out of abundance of caution.

-Recalled products:
Product Description: Clopidogrel 75mg Tablets, 1,000 Count Bottle, GSMS NDC: 51407-032-10, Lot #: GS046745, Expiration Date: 12/2023
Product Description: Atenolol 25mg Tablets, 1,000 Count Bottle, GSMS NDC: 60429-027-10, Lot #: GS046745, Expiration Date: 12/2023

Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Clopidogrel is prescribed to lower the risk of having a stroke, blood clot, or serious heart problem for patients who have had heart attack, severe chest pain, or circulation problems as indicated in the product labeling. For more drug label information about clopidogrel bisulfate visit: DailyMed - CLOPIDOGREL- clopidogrel bisulfate tablet, film coated (nih.gov). For more drug label information about atenolol visit: DailyMed - ATENOLOL tablet (nih.gov)

Patients who suddenly stop taking atenolol, as would happen if clopidogrel were misplaced in the atenolol-labeled bottle, are at increased risk for ischemic (angina, myocardial infarction), hypertensive and arrhythmic adverse events relating to rapid withdrawal of beta antagonism. Further, patients who are on atenolol are frequently on concomitant anticoagulant and antiplatelet medications and would be at increased risk for bleeding if clopidogrel were added to the regimen. To date, GSMS, Inc. has not received any reports of adverse events related to the use of the products as part of this recall.

The lot under GSMS, Inc.’s voluntary recall has been primarily sold to AmerisourceBergen, and McKesson. AmerisourceBergen and McKesson are instructed to immediately stop distribution, quarantine all remaining products in their control, and return the recalled product to GSMS, Inc. They are also instructed to provide their customers, i.e., pharmacies and consumers, a copy of GSMS, Inc.’s recall notification, recall response form, and letter to consumers, patients, and caregivers.

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

In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Golden State Medical Supply, Incorporated
Brand name: Golden State Medical Supply, Incorporated
Product recalled: Clopidogrel 75mg Tablets, Atenolol 25mg Tablets
Reason of the recall: Due to Label Mix-up
FDA Recall date: September 29, 2022

fda.gov
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Proper Trade LLC/My Stellar Lifestyle is voluntarily recalling Wonder Pill lot 20210912 and lot 31853-501, expiry 09/24, packaged in 10-count blisters co-packaged in a carton and in 60-count bottles to the consumer level. Proper Trade LLC/My Stellar Lifestyle was notified by Amazon that laboratory analysis has found... See More the product to be tainted with tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in Wonder Pill capsules makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.

Consumers with underlying medical issues who take the Wonder Pill with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Proper Trade LLC/ My Stellar Lifestyle has not received any reports of adverse events related to this recall.

The product is marketed as a dietary supplement for male sexual enhancement and is packaged in 10-count blisters co-packaged in a carton, ASIN B0B6CWC9NK, and packaged in a 60-count bottle. The affected lots include lot numbers’ 20210912 & 31853-501, Expiry 09/24. The product can be identified by the labels below. The product was distributed via the internet and fulfilled by Amazon at www.amazon.com and Walmart at www.walmart.com, nationwide in the USA.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Proper Trade LLC/ My Stellar Lifestyle is notifying its customers by this press announcement and sending Amazon & Walmart messages to its customers and is arranging for return of all recalled products. Consumers that have Wonder Pill capsules which is being recalled should stop using the product.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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

Company name: Proper Trade LLC/My Stellar Lifestyle
Brand name: My Stellar Lifestyle
Product recalled: Wonder Pill Capsules
Reason of the recall: Product contains undeclared tadalafil
FDA Recall date: September 28, 2022

Source: fda.gov
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