Category: Pharmacy

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:
Due to detection of N-Nitrosodimethylamine (NDMA)
Company Name:
Amneal Pharmaceuticals LLC
Brand Name:
Amneal
Product Description:
Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg

Company Announcement

Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Consumer Level.

Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels. FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. Further scientific evaluations are ongoing at Amneal.

To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall. (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:
Contains undeclared minoxidil
Company Name:
MasterPharm, LLC
Brand Name:
MasterPharm, LLC
Product Description:
Finasteride Plus 1.25mg, capsules

Company Announcement

MasterPharm, LLC. is voluntarily recalling 1 lot of Finasteride Plus 1.25mg, capsules to the consumer level. The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products. The undeclared minoxidil was found when tested with an independent testing laboratory.

Risk Statement: Consumption of undeclared minoxidil would be expected to result in low blood pressure, rapid heartbeat, and salt and water retention causing swelling. Consequently, patients may be at risk for developing heart failure or other heart damage. Excess fluid between the heart and the sac surrounding the heart has also been reported in association with minoxidil use. MasterPharm, LLC. has received 33 reports of increased heart rate, retention of water, dizziness and low blood pressure. (more…)

Summary

Company Announcement Date:
April 23, 2020
FDA Publish Date:
April 27, 2020
Product Type:
Drugs
Reason for Announcement:
presence of particulate matter
Company Name:
QuVa Pharma, Inc.
Brand Name:
QuVa
Product Description:
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe

Company Announcement

SUGAR LAND, Texas, April 23, 2020 — QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi. Fresenius Kabi recalled multiple lots of Ketorolac on April 20, 2020 due to the presence of particulate matter found in the reserve sample vials.

QuVa has reached out to all hospital pharmacy customers who purchased product from the lots affected and has asked them to: quarantine anything that is in stock to prevent use in direct patient care; complete a return response form to capture the amount of unused product; and return the finished goods to QuVa for destruction. (more…)

Summary

Company Announcement Date:
April 20, 2020
FDA Publish Date:
April 20, 2020
Product Type:
Drugs
Reason for Announcement:
Presence of Particulate Matter
Company Name:
Fresenius Kabi USA, LLC
Brand Name:
Fresenius Kabi
Product Description:
Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL

Company Announcement

Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen and polyamides. Particulate matter was found in eight reserve sample vials.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the shortterm (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine injection should not exceed 5 days.

Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019, as well as a copy of the label:

Product Name/Product size

NDC Number

Product Code

Batch Number

Expiration Date

First Ship Date

Last Ship Date

Ketorolac Tromethamine Injection, USP, 30 mg / mL, 1 mL fill in a 2 mL amber vial

63323-162-01

160201

6118737 04/2020 05/30/2018 06/27/2018
6118902 04/2020 08/01/2018 08/15/2018
6119052 05/2020 06/25/2018 07/25/2018
6119752 08/2020 09/28/2018 12/06/2018
6122349 07/2021 09/16/2019 11/04/2019
6122538 09/2021 11/01/2019 12/16/2019
Ketorolac Tromethamine Injection, USP, 60 mg / 2 mL (30 mg / mL), 2 mL fill in a 2 mL amber vial 63323-162-02 160202 6119229 06/2020 08/09/2018 10/30/2018
6119273 06/2020 09/26/2018 03/30/2019
6119843 09/2020 11/11/2019 01/07/2020
6121115 02/2021 03/30/2019 04/22/2019
6121451 03/2021 04/29/2019 08/05/2019
6121452 03/2021 07/12/2019 10/22/2019
6121496 03/2021 06/21/2019 12/10/2019

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. (more…)