The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1360-2020·Announced 2020-07-08

Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

The Harvard Drug Group is recalling Metformin Hydrochloride Extended-Release Tablets due to potential NDMA impurity levels above established limits.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant chemical impurities like NDMA.

Plain-English summary

The Harvard Drug Group is recalling 1,906 cartons of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg. The product is distributed in 100-tablet unit dose cartons (10 x 10) and is available by prescription only. The specific lot number is T-02134, with an expiration date of 09/2020.

The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation involving the potential presence of the impurity Nitrosodimethylamine (NDMA) above established levels. The product was manufactured by Apotex, Inc., in Toronto, Ontario, Canada, for Apotex Corp. in Weston, FL, and distributed by Major Pharmaceuticals in Livonia, MI.

The recall is classified as Class II by the FDA. The distribution pattern is listed as Nationwide USA. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC…
Manufacturer
The Harvard Drug Group
Category
Drug — Prescription Medication
Hazard
Affected units
1,906

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot T-02134
  • exp 09/2020

Distribution

Distributed nationwide across the United States.

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