Recall of Metformin Hydrochloride ER Tablets

Amneal Pharmaceuticals LLC Bridgewater is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Consumer Level. They were alerted by the U.S. FDA when testing seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, it showed Nitrosodimethylamine (NDMA) amounts above acceptable consumer FDA levels. Out of caution Amneal agreed to recall all seven lots and has not reported any adverse events directly related to the recall.

*Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.

Why is it being recalled?

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.1 With levels above admissible according to the FDA it is being recalled ensuring no adverse reactions arise during consumption. If any adverse reactions are experienced you can submit them online here or find more information on how to mail or fax here.

What products are being recalled?

Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.1

The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.

Metformin HCl Extended Release Tablets, USP, 500 mg

Metformin HCl Extended Release Tablets, USP, 750 mg

*Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.1

What’s next?

  • Because Metformin is used to treat serious medical conditions, patients taking the recalled Metformin should continue taking their medicine until they have a replacement product.
  • To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
  • Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another product not affected by this recall or an alternative treatment option.

Sources:

  1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended#recall-announcement
  2. https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin

Infant Ibuprofen Recall

Tris Pharma, Inc. has issued a voluntary nationwide recall of infant ibuprofen amid concerns the medication, which was destined to be sold at several major retailers, may contain a higher concentration of ibuprofen than labeled. The lots were sold under Walmart, CVS Pharmacy and Family Dollar. As of now, the company has not received any reports of serious adverse events related to the recall.

Why is it being recalled?

Per Tris Pharma, “The reason for the recall was a potential higher concentration of Ibuprofen of less than 10% above the specified limit in some bottles from these three batches. Safety issues or toxicity is generally accepted to be a concern in infants at doses more than 700% of the recommended dose.” If Ibuprofen is taken in excess, a side effect could be permanent kidney injury, nausea, vomiting, stomach pain, diarrhea, tinnitus, headaches or possible stomach bleeding.

What products are recalled?

Affected products are labeled “Infants’ Ibuprofen Concentrated Oral Suspension” and were labeled to contain 50 mg. of ibuprofen per 1.25 mL. 

NDC; LOT; EXPIRATION; DESCRIPTION ; COMPANY;
49035-125-23 00717009A
00717015A
00717024A
02/19
04/19
08/19
Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle Wal-Mart Stores Inc
59779-925-23 00717024A 08/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle CVS Pharmacy
55319-250-23 00717024A 08/19 Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle Family Dollar Services Inc.

Next steps you should take

  • To determine whether a specific product has been recalled, patients should look at the drug name and see if the NDC, Lot, and expiration dates matches those listed above.
  • If you have one of the recalled medicines, follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
  • Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email. 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. 

Need help?

Contact your Tria Health pharmacist today for additional assistance with the recall process: 1.888.799.8742

Source: https://www.fda.gov/Safety/Recalls/ucm627780.htm

Losartan Recall

Recall

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan. The FDA will continue to investigate this issue and provide additional information when it becomes available. The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.

Why is it being recalled?

N-Nitrosodiethylamine, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

What products are recalled?

The product can be identified as Losartan Potassium Hydrochlorothiazide, 100 mg/25 mg tablets in 1000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020. It is important to note that this recall encompasses less than 1% of the national Losartan drug products. This product was distributed nationwide to distributors. The affected product was not distributed prior to October 8, 2018.

Next steps you should take

  • Because Losartan is used in medicines to treat serious medical conditions, patients taking the recalled Losartan should continue taking their medicine until they have a replacement product.
  • To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
  • If a patient is taking one of the recalled medicines, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
  • Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another product not affected by this recall or an alternative treatment option.

 

Need help?

Contact your Tria Health pharmacist today for additional assistance with the recall process: 1.888.799.8742

 

Source: https://www.fda.gov/Safety/Recalls/ucm625492.htm

Children’s Medicine Recall

Recall

The FDA has recently released a statement regarding more than 30 King Bio medicines for children and infants. A “small percentage” of the medicines tested positive for microbial contamination. King Bio is notifying its distributors and customers by letter and is arranging for return and/or replacement of all recalled products. Consumers/distributors/retailers that have product which is being recalled should discontinue use/distribution and contact King Bio at recall@kingbio.com to make arrangements to return product. These products were distributed Nationwide to distributors and retail stores August 2017 – July 2018.1

What is a Microbial Contamination?

Microbial contamination is the unintended introduction of bacteria into a controlled area (petri dish, stock media, work station). Administration or use of drug products with microbial contamination, could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. King Bio has not received reports of injury or illness to date.

What Products are Recalled?

You can find a list of the products affected on the FDA’s website.

Have any Questions for us?

Contact the Tria Health Help Desk at 1.888.799.8742

 

Source:

  1. https://www.fda.gov/Safety/Recalls/ucm617945.htm

Hypothyroidism Medication Recall

Recall

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine. The FDA encourages patients and health care professionals to report any adverse reaction to the MedWatch program.

Why are these medications being recalled?

These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to a 2017 inspection which discovered deficiencies with Current Good Manufacturing Practices (cGMP). While there is risk involved in taking this product, to date, Westminster Pharmaceuticals has not received any reports of adverse events related to this product.

What products are recalled?

You can find a detailed list of the products, lot numbers and expirations dates listed on the FDA’s website.

Next steps you should take

  • Because Levothyroxine and Liothyronine is used to treat serious medical conditions, patients taking the recalled medicines should continue taking their medicine until they have a replacement product.
  • Patients who are taking Levothyroxine or Liothyronine should contact the pharmacy that dispensed their medication to determine if their prescription is affected.   If your medication is one of the affected products the pharmacy can work with your physician to obtain a new prescription if necessary.

Need help?

Contact your Tria Health pharmacist today for additional assistance with the recall process: 1.888.799.8742

 

Source: https://www.fda.gov/Safety/Recalls/ucm616601.htm