The Recall Desk
SevereFDA (Drugs)·D-1333-2020·Announced 2020-07-01

PD-Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

PD-Rx Pharmaceuticals is recalling 1,969 bottles of Metformin Hydrochloride Extended Release 500 mg because FDA analysis detected NDMA impurity above acceptable levels.

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, which corresponds to a 'Severe' rating under the rubric for significant potential health risks, specifically involving impurities above acceptable intake levels.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling 1,969 bottles of Metformin Hydrochloride Extended Release 500 mg tablets. The affected products are distributed in the United States and include various bottle sizes (30, 60, 90, 100, and 180 tablets) under specific NDC codes and lot numbers listed in the recall notice.

The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected lots of Metformin Hydrochloride Extended Release and contact their healthcare provider for alternative treatment options. The specific lot numbers and expiration dates are detailed in the official recall documentation.

The recalled product

Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE EXTENDED RELEASE
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
1,969

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 (20)

  • Lots: a) A20B02
  • I19D03
  • J19A98
  • K19E32
  • L19C86 Exp. 12/31/2020
  • b) I19D55
  • I19F50
  • K19A18
  • K19D87
  • L19B34
  • L19D23
  • L19E74 Exp. 12/31/2020
  • c) I19E91
  • I19F33
  • J19B88
  • J19E70
  • K19D26
  • L19A65 Exp. 12/31/2020
  • d) I19C21 Exp. 08/21/2020
  • I19C57

Distribution

Distribution scope not specified by the agency.

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Same brand · METFORMIN HYDROCHLORIDE EXTENDED RELEASE

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Same hazard · ndma impurity

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