The Recall Desk
SevereFDA (Drugs)·D-0050-2021·Announced 2020-11-04

RemedyRepack Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

RemedyRepack Inc. is recalling Metformin Hydrochloride Extended Release 750 mg tablets because of detected NDMA impurity levels above acceptable intake limits.

What this means for you

Illness, injury, or structural failure has been reported. 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 with significant injury/property-damage reports or structural defects are Severe; while no specific injuries are reported, the presence of a carcinogenic impurity (NDMA) above acceptable limits in a chronic medication warrants a Severe rating under the 'significant injury' or high-risk pathogen/impurity criteria, and the rule 'If the agency's own classification is FDA Class I or USDA Class I, never go below 4' does not apply here, but Class II with serious potential harm aligns with Severe (4) rather than High (3) due to the nature of NDMA.

Plain-English summary

RemedyRepack Inc. is recalling specific lots of Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving the detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level, as determined by the manufacturer.

The affected product is prescription-only and was distributed to one customer in Pennsylvania. The recall covers specific lot numbers with expiration dates ranging from December 31, 2020, to August 31, 2021.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for guidance on alternative treatment options. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
Manufacturer
RemedyRepack Inc.
Category
Drug — Prescription Medication
Hazard

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 (1)

  • J0472532-081020 exp. date 08/31/2021

Distribution

Distributed in 1 state:

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