Category: Drugs

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Distributed without FDA clearance may pose health risk
Company Name:
Chengdu Ai Qin E-commerce Co., Ltd
Brand Name:
TTDeye
Product Description:
Colored contact lenses

Company Announcement

On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health.

The following products are being recalled:

Name of Product

Black Starshine

Diamonds Starlight

Flower Brown

Flower Grey

Radial Brown

Radial Pink

Devil Red

Brand TTDeye TTDeye TTDeye TTDeye TTDeye TTDeye TTDeye
Lot Codes B16112100 B16112203 B16112210 B16112231 B16112109 B16112110 B16112201

These colored contact lenses were sold through the website www.ttdeye.comExternal Link Disclaimer and shipped directly to the customer from 08/05/2019 – 10/11/2019.

The recalled products were manufactured August 2018 and may be identified by name of the product and the date of manufacture, “2018-08”, found on the package label.

If you have received this product, immediately cease use and contact the company via online chat at www.ttdeye.comExternal Link Disclaimer between 9AM and 6PM (GMT+8) or contact the company via email at info@ttdeye.com (24 hours) for further information.

The company has received no complaints to date. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Over-the-Counter Drugs
Reason for Announcement:
Incorrect dosing cups
Company Name:
GSK Consumer Healthcare
Brand Name:
Robitussin
Product Description:
Cough and cold products

Company Announcement

GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children’s Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children’s Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.

There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the instructions for use). Children’s Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan HBr USP and guaifenesin USP 100 mg per 10 mL, and is labeled for children 4 and older, as well as adults. Children’s Dimetapp Cold & Cough contains 2 mg brompheniramine maleate USP, 10 mg dextromethorphan HBr USP, and 5 mg phenylephrine HCl USP per 10 mL, and is labeled for children 6 and older, as well as adults. Symptoms of overdose of either product may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behaviour; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention. As of the date of the recall announcement, GSK Consumer Healthcare has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Detection of N-Nitrosodimethylamine (NDMA)
Company Name:
Lupin Pharmaceuticals, Inc
Brand Name:
Lupin
Product Description:
Metformin Hydrochloride Extended-release Tablets

Company Announcement

Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Due to detection of N-Nitrosodimethylamine (NDMA)
Company Name:
Apotex Corp
Brand Name:
Apotex Corp
Product Description:
Metformin Hydrochloride Extended-Release Tablets, USP 500mg

Company Announcement

Apotex is expanding the previously announced Retail Level recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg that was initiated on May 29, 2020 to Consumer Level.

Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US. Apotex stopped selling this product in the US in February 2019, and there remains only limited product on the market. To date, Apotex has not received any reports of adverse events related to use of the product. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Due to detection of N-Nitrosodimethylamine (NDMA)
Company Name:
Teva Pharmaceuticals USA Inc.
Brand Name:
Actavis
Product Description:
Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg

Company Announcement

Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Due to detection of N-Nitrosodimethylamine (NDMA)
Company Name:
Marksans Pharma Limited, India
Brand Name:
Time-Cap Labs, Inc.
Product Description:
Metformin Hydrochloride Extended-Release Tablets, USP 500mg

Company Announcement

Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/day.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. Marksans Pharma Limited has not received any reports of adverse events related to this recall to date. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Super potency
Company Name:
Acella Pharmaceuticals, LLC
Brand Name:
Acella
Product Description:
30-mg, 60-mg and 90-mg NP Thyroid®

Company Announcement

Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development. Patients should talk to their healthcare professional before they stop taking their NP Thyroid medicine. To date, Acella has received two reports of adverse events known to be related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Unapproved new drug
Company Name:
Biota Biosciences, LLC
Brand Name:
Biota Biosciences
Product Description:
Cannabidiol (CBD) Complex, Curcumin Complex, Cannabidiol + Curcumin

Company Announcement

Seattle, Washington, Biota Biosciences is voluntarily recalling the following lots in the table below of Sterile Cannabidiol (CBD) previously listed as Cannabidiol (CBD) Complex, Sterile Curcumin previously listed as Curcumin Complex, Sterile Cannabidiol (CBD) + Curcumin previously listed as Cannabidiol (CBD) + Curcumin Complex Injectables to the customer level. These injectable products are being recalled because they were marketed without FDA approval. The products claims on our website make these products unapproved new drugs. Further, the products are misbranded because the labeling fails to bear adequate directions for use.

Product Name Strength(mg)
(mg/mL)
Multiple Dose Vial Size Lot Expiration
Sterile Cannabidiol (CBD) previously listed as Cannabidiol (CBD) Complex 4 10 mL 2H071219P
2H0712019P
2H07122019P
07/12/2021
50 10 mL 101019P
1010019P
10102019P
10/10/2021
Sterile Curcumin previously listed as Curcumin Complex 4 10 mL 2H071219CCD 2H0712019CCD 2H07122019CCD 07/12/2021 4 10 mL 2H071219CCD
2H0712019CCD
2H07122019CCD
07/12/2021
50 10 mL 071219CCD
0712019CCD
07122019CCD
07/12/2021
Sterile Cannabidiol (CBD) + Curcumin previously listed as Cannabidiol (CBD) + Curcumin Complex 50 10 mL 101019PC
1010019PC
10102019PC
10/10/2021

Risk Statement: Unapproved new drugs injected into the bloodstream for which safety and efficacy have not been established could pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Biota Biosciences has not received any reports of adverse events related to this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Contains lead
Company Name:
Summitt Labs
Brand Name:
KORE ORGANIC
Product Description:
Watermelon CBD oil tincture

Company Announcement

Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon CBD Oil Tincture, 30 ml bottle, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm. When informed of this, Summitt Labs issued an immediate voluntary recall and started an internal investigation. As part of this investigation Summitt Labs had a sample from Batch #730 Lot #K018 tested at an ISO/IEC accredited lab. Lead results were 500 ppb (.5ppm), which is within the legal limits as defined by the State of Florida. However, based on the test from the Florida Department of Agriculture and Consumer Services, Summitt Labs initiated, and will complete, a full recall of Batch #730 Lot #K018 in full cooperation with the FDA and Florida Department of Agriculture and Consumer Services.

Summitt Labs is an inspected and licensed facility under the Florida Department of Food and Agriculture and Consumer Services to produce products containing CBD but the Federal Food and Drug Administration does not consider CBD to be a legal drug or dietary supplement.

Ingestion of KORE ORGANIC Watermelon CBD Oil Batch #730 Lot #K018 containing lead could result in high lead exposure. According to the Florida Department of Health, acute lead poisoning could have signs and symptoms including but not limited to; Pain, Muscle Weakness, Paresthesia, Abdominal Pain, Nausea, Vomiting, Diarrhea, Constipation, Poor appetite, Weight Loss, Symptoms associated with encephalitis, Metallic taste in the mouth, Shock, Hemolysis, and Kidney Damage. To this date, Summitt Labs has not had a call, complaint or report of any adverse effect from the use of this product. (more…)