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Recall

Updated: July 23, 2021 12:03 AM

July 23, 2021 12:03 AM

“Company name: HIS
Brand name: HIS
Product recalled: Dietary Supplement for Weight Loss
Reason of the recall: Undeclared Sibutramine
FDA Recall date: July 22, 2021
Recall details: Palisades Park, NJ, HIS is voluntarily recalling all lots and all presentations of Miss Slim (10 count & 30 count... See More capsules) to the consumer level. HIS decided to recall Miss Slim after it was contacted by the FDA regarding the presence of sibutramine in the product.

Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues. The presence of sibutramine in Miss Slim renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to a recall. To date, HIS has not received any reports of adverse events related to this recall.

The product is marketed as a dietary supplement and is packaged 10 count UPC (742137605030) and 30 count UPC (609728434472) capsules. The product sold online at missslimusa.com.

Risk Statement: Products containing sibutramine pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

HIS is notifying its customers by website missslimusa.com and is arranging for return of all recalled products. Consumers that have Miss Slim which is being recalled should stop using it. 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.

Check the full recall details on fda.gov

Source: FDA
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July 19, 2021 9:02 PM

“Company name: Alpha Male Plus
Brand name: Alpha Male Plus
Product recalled: Alpha Male Plus Male Enhancer fruit chew
Reason of the recall: Undeclared Tadalafil
FDA Recall date: July 19, 2021
Recall details: Tucson, AZ, Alpha Male Plus is voluntarily recalling all lots within expiry of Alpha... See More Male Plus Male Enhancer fruit chews to the consumer level. FDA analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in a FDA approved product for the treatment of male erectile dysfunction. The presence of tadalafil in Alpha Male Plus Male Enhancer renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Consumers with underlying medical conditions who take Alpha Male Plus Male Enhancer 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, Alpha Male Plus has not received any reports of adverse events related to this recall.

The tainted Alpha Male Plus Male Enhancer product was manufactured by Dr Manuel Mascarenas M.D. in Tucson, Arizona located at 5190 E Farness Dr Ste 104, 85712. Dr Mascarenas is the originator and manufacturer of these products for the global market. Alpha Male Plus was selected to act as the US distributor and distribute these products for the US market.

The tadalafil ingredient was never disclosed or made known to its US distributor and was only discovered through FDA laboratory analysis. Dr Manuel Mascarenas is solely responsible for the creation, formulation and proliferation of this product. Through the use of concealment, dishonest means and an unknowing 3rd party Dr Mascarenas was able to begin distributing this mislabeled and potentially harmful product to the US market.

Alpha Male Plus was marketed as a dietary supplement for male sexual enhancement and is packaged in 1strip per foil pouch within a cardboard box, UPC [8 60003 03770 6] [8 60003 74512 0].

The affected Alpha Male Plus Male Enhancer includes all lots. The product was distributed nationwide in the USA via internet directly to consumers via their website.

Company is notifying its distributors and customers by e-mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using or return to place of purchase/discard/contact their doctor, etc.

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

Check the full recall details on fda.gov

Source: FDA
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July 19, 2021 3:02 PM

“Company name: Pfizer
Brand name: CHANTIX
Product recalled: Smoking cessation treatment
Reason of the recall: N-Nitroso Varenicline content above ADI level
FDA Recall date: July 19, 2021
Recall details: Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and... See More eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. 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.

Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke. Smoking is also associated with many other cancers. CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options.

To date, Pfizer has not received any reports of adverse events that have been related to this recall.

The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from June 2019 to June 2021. 

For more recall details including the NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets check: fda.gov

Source: FDA
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July 14, 2021 9:01 PM

“Company name: Johnson& Johnson
Brand name: Neutrogena, Aveeno
Product recalled: Sunscreen
Reason of the recall: Testing identified low levels of benzene
FDA Recall date: July 14, 2021
Recall details: Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five NEUTROGENA® and AVEENO® aerosol sunscreen... See More product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected products and follow the instructions set forth below.

The only sunscreen products impacted are aerosol products, specifically: NEUTROGENA® Beach Defense® aerosol sunscreen:
- NEUTROGENA® Cool Dry Sport aerosol sunscreen
- NEUTROGENA® Invisible Daily™ defense aerosol sunscreen
- NEUTROGENA® Ultra Sheer® aerosol sunscreen
- AVEENO® Protect + Refresh aerosol sunscreen

Benzene is classified as a human carcinogen, a substance that could potentially cause cancer depending on the level and extent of exposure. Benzene is ubiquitous in the environment. Humans around the world have daily exposures indoors and outdoors from multiple sources. Benzene can be absorbed, to varying degrees, by inhalation, through the skin, and orally. Based on exposure modeling and the Environmental Protection Agency’s (EPA) framework, daily exposure to benzene in these aerosol sunscreen products at the levels detected in our testing would not be expected to cause adverse health consequences. Out of an abundance of caution, we are recalling all lots of these specific aerosol sunscreen products.

While benzene is not an ingredient in any of our sunscreen products, it was detected in some samples of the impacted aerosol sunscreen finished products. We are investigating the cause of this issue, which is limited to certain aerosol sunscreen products. Sunscreen use is critical to public health. Melanoma incidences continue to increase worldwide, and the majority of cases are caused by excessive sun exposure. It is important that people everywhere continue to take appropriate sun protection measures, including the continued use of alternative sunscreen.

The recalled sunscreen products are packaged in aerosol cans. The products were distributed nationwide through a variety of retail channels.

Consumers should stop using these specific products and appropriately discard them.

Check the full recall details on fda.gov

Source: FDA
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July 13, 2021 8:00 PM

“Company name: Innoveix Pharmaceuticals, Inc.
Brand name: Innoveix Pharmaceuticals, Inc.
Product recalled: Injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg
Reason of the recall: Potential lack of sterility assurance
FDA Recall date: July 13, 2021
Recall details: Innoveix Pharmaceuticals, Inc. is voluntarily recalling the following lots... See More of sterile compounded drug products, within expiry. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA.

Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening. To date, Innoveix Pharmaceuticals, Inc. has not received any reports of adverse events related to this recall. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority.

The affected products are injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg. The products can be used for various indications as prescribed. The products can be identified by an Innoveix Pharmaceuticals, Inc. label. The products were distributed in glass vials contained in a small 3 inch by 3 inch white box.

Products were distributed nationwide to both customers and/or medical facilities. A full list of the affected products with the applicable lot numbers and expiration dates is as follows:

Product Lot/Expiry
Semorelin / Ipamorelin 3mg Lot# SIP210; Exp: 12/15/2021
Lot# SIP215; Exp: 01/14/2022
Lot# SIP220; Exp: 01/23/2022

AOD-9604 3mg Lot# AOD205; Exp: 11/09/2021
Lot# AOD210; Exp: 11/18/2021
Lot# AOD 215; Exp: 12/15/2021
Lot# AOD202; Exp: 11/09/2021

Check the full recall details on fda.gov

Source: FDA
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July 1, 2021 8:00 PM

“Company name: Natural Instinct
Product recalled: Working Dog Duck, Pure Duck, Working Dog Puppy, Duck Carcass, Duck Necks
FSA Recall date: 07/01/2021
Recall details: Natural Instinct Ltd is recalling several dog food products containing duck because salmonella has been found in the products.

- Working Dog Duck... See More (1kg and 2x500g). Use by: 08 January 2022 15 January 2022 22 January 2022 13 February 2022 20 February 2022 11 March 2022 18 March 2022.
- Pure Duck (1kg and 2x500g). Use by: 08 January 2022 15 January 2022 22 January 2022 13 February 2022 20 February 2022 11 March 2022 18 March 2022.
- Working Dog Puppy (1kg and 2x500g). Use by: 15 January 2022 22 January 2022 13 February 2022 20 February 2022 11 March 2022.
- Duck Carcass (Pack of 2). Use by: 08 January 2022 15 January 2022 20 February 2022.
- Duck Necks (Pack of 6). Use by: 15 January 2022 22 January 2022.

(Pet owners) If you have bought any of the above products do not use them. Instead, return them to the store from where they were bought for a full refund. When handling and serving raw pet food it is always advised to clean utensils and feeding bowls thoroughly after use.

Consumers should wash hands thoroughly after handling raw pet food, bowls, utensils or after contact with the faeces of animals. Raw pet food should be stored separately from any food (especially ready to eat foods). Care should be taken when defrosting to avoid cross contamination of foods and surfaces.

In humans, symptoms caused by salmonella usually include fever, diarrhoea and abdominal cramps. Infected animals may not necessarily display signs of illness, but symptoms can include diarrhoea.

Check the full recall details on food.gov.uk

Source: FSA
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Diagnosis: Salmonella

July 1, 2021 6:02 PM

“Company name: Ardil Commercial
Brand name: Limar
Product recalled: Hand sanitizer
Reason of the recall: Packaged in bottles that resemble drink containers
FDA Recall date: July 01, 2021
Recall details: Santo Domingo, Dominican Republic – Ardil Comercial is voluntarily recalling one lot of Limar Hand Sanitizer, packaged... See More in 4 oz bottles to the consumer level. The hand sanitizer is being recalled because it is packaged in containers that resemble water bottles.

The product poses a risk of ingestion. Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute. 

To date, Ardil Comercial has not received any reports of adverse events related to this recall. The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in 4 oz bottles. under the brand Limar. The product can be identified by the bottle’s labels pictured below.  The affected product lots include the following lot number: 079932-4611-05-J with the following expiration date: May 2022. Hand Sanitizer 4 oz Limar was distributed nationwide to a distributor who may have further distributed nationwide in the USA.

Ardil Comercial is notifying its distributors and customers by telephone, press release and is arranging for a replacement of all recalled products. Consumers and distributors that have the product which is being recalled should return to place of purchase. 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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July 1, 2021 11:00 AM

“Company name: Teva Pharmaceuticals
Brand name: Teva
Product recalled: Topotecan Injection 4 mg/4 mL (1 mg/mL)
Reason of the recall: Presence of particulate matter
FDA Recall date: July 01, 2021
Recall details: Teva Pharmaceuticals has initiated a voluntary recall of lot 31328962B of Topotecan Injection 4 mg/4... See More mL (1 mg/mL), to the retail/institutional level in the United States. This voluntary recall was initiated based on a complaint received from a pharmacy after a single glass particle was observed inside one vial. After further examination of the complaint sample, two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.

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 exposure to impacted product is remote or unlikely.

To date, Teva has received no further complaints or reports of illness or injury.

- Carton NDC: 0703-4714. Vial NDC: 0703-4714-71. Lot# 31328962B. Exp. Date: 04/2022

Topotecan Injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy and for patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. It is also indicated for treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin. It is packaged in 4 mg/4 mL single use vials. The affected product information is listed in the table above. Teva distributed the product nationwide to six of its Wholesale customers.

Teva notified its customers on June 18th 2021 and asked that the lot be recalled and to make arrangements for impacted product to be returned. Any consumer who has questions or concerns should first consult with their health care provider(s).

Check the full recall details on fda.gov

Source: FDA
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June 24, 2021 8:00 PM

“Company name: Happy Hounds Wales Ltd
Product recalled: Frozen Beef Mince 993, Frozen Lamb & Beef 992/993, Frozen Turkey and Beef 991/993, Frozen Diced Heart
FSA Recall date: 06/24/2021
Recall details: Happy Hounds Wales Ltd is recalling certain types of frozen raw dog food because of the... See More presence of salmonella in the products.

- Product: Frozen Beef Mince 993 (1kg)
- Batch code: 993
- Best before: 31/05/2022

- Product: Frozen Lamb & Beef 992/993 (1kg)
- Batch code: 992/993
- Best before: 31/05/2022

- Product: Frozen Turkey and Beef 991/993 (1kg)
- Batch code: 991/993
- Best before: 01/06/2022

- Product: Frozen Diced Heart (1.5kg)
- Batch code: 993
- Best before: 01/06/2022

Pet owners: If you have bought any of the above products do not use them. Instead, return them to the store from where they were bought for a full refund.

Salmonella is a bacterium that can cause illness in humans and animals. The product could therefore carry a potential risk, because of the presence of salmonella, either through direct handling of the pet food, or indirectly, for example from pet feeding bowls, utensils or contact with the faeces of animals.

In humans, symptoms caused by salmonella usually include fever, diarrhoea and abdominal cramps. Infected animals may not necessarily display signs of illness, but symptoms can include diarrhoea.

When handling and serving raw pet food it is always advised to clean utensils and feeding bowls thoroughly after use. Consumers should wash their hands thoroughly after handling raw pet food, bowls, utensils or after contact with the faeces of animals. Raw pet food should be stored separately from any food (especially ready to eat foods). Care should be taken when defrosting to avoid cross-contamination of foods and surfaces.

Check the full recall details on food.gov.uk

Source: FSA
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June 22, 2021 3:01 PM

“Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Hand sanitizer and hand sanitizing wipes
Reason of the recall: Microbial contamination
FDA Recall date: June 22, 2021
Recall details: Sanit Technologies LLC d/b/a Durisan, is providing an additional 5 label illustrations and product sizes... See More for customers that might not have been able to clearly identify containers of Non-Alcohol Hand Sanitizer products that were added to the voluntary recall initiated on March 24, 2021, and expanded by the April 10 and May 14, 2021 notices. To avoid any confusion, this press release provides copies of label illustrations for the recalled products.

Durisan Non Alcohol Antimicrobial Hand Sanitizer products became contaminated with a common municipal water supply borne bacteria, Burkholderia contaminans. Use of a hand sanitizer contaminated with Burkholderia contaminans, generally considered to be of low virulence, can range from no reaction to possible infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems.

To date, no qualified reports of adverse reactions have been reported related to this recall.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available. The list of the lot numbers of the recalled products, which have a 24-month expiration, is included below.

Consumers and customers in possession of Durisan Non Alcohol Antimicrobial Hand Sanitizer products with these numbers in any form factor are encouraged to contact Durisan to return it.

The product is packaged in sizes ranging from 18mL credit card to 1-gallon containers. The lot number can be found in black print on the bottom of the package. Durisan Antimicrobial Solutions Hand Sanitizer Sizes With the Following Identification

- Volume mL: 18. Volume oz: 0.61. UPC: 8 52379 00614 1. NDC: 71120-112-01.
- Volume mL: 50. Volume oz: 1.69. UPC: 8 52379 00634 9. NDC: 71120-611-20.
- Volume mL: 118. Volume oz: 4. UPC: 8 52379 00612 9. NDC: 71120-112-10.
- Volume mL: 236. Volume oz: 8. UPC: 8 52379 00635 6. NDC: 71120-112-11.
- Volume mL: 250. Volume oz: 8.45. UPC: 8 52379 00611 0. NDC: 71120-611-03.
- Volume mL: 300. Volume oz: 10. UPC: 8 52379 00697 4. NDC: 71120-112-08.
- Volume mL: 550. Volume oz: 18.59. UPC: 8 52379 00620 2. NDC: 71120-112-06.
- Volume mL: 1000. Volume oz: 33.81. UPC: 8 52379 00610 3. NDC: 71120-112-05.
- Volume mL: 3785. Volume oz: 128. UPC: 8 52379 00621 9. NDC: 71120-611-05.
- Volume mL: 160 Ct Wipe. Volume oz: 5.63. UPC: 8 52379 00631 8. NDC: 71120-111-01.
- Volume mL: 80 Ct Wipe. Volume oz: 2.81. UPC: 8 52379 00632 5. NDC: 71120-111-03.
- Volume mL: 240 Ct Wipe. Volume oz: 8.44. UPC: 8 52379 00633 2. NDC: 71120-111-03.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Check the full recall details on fda.gov

Source: FDA
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