The Recall Desk
SevereFDA (Drugs)·D-1307-2020·Announced 2020-06-24

PD-Rx Recalls Metformin HCL ER Tablets Due to NDMA Impurity

PD-Rx Pharmaceuticals is recalling specific lots of metformin HCL ER 500 mg tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

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 severity score under the rubric for significant potential health risks.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling 3,703 bottles of metformin HCL ER USP 500 mg tablets. The recall affects multiple package sizes, including 30, 60, 90, 120, 180, and 500-tablet bottles, distributed in the United States.

The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. The affected lots have expiration dates of 06/30/2020. Specific lot numbers are listed in the official recall notice.

Consumers should check their medication bottles for the NDC codes and lot numbers listed in the recall notice. If the medication matches the recalled lots, patients should stop using it and consult their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorp
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
3,703

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) D19C80
  • F19C39
  • H19A55
  • H19D56
  • I18E0 Exp. 06/30/2020
  • b) D19A66
  • E19C15
  • F19D60 Exp. 06/30/2020
  • c) E19D32
  • J18B83
  • C19D25
  • C19E78
  • D19C60
  • D19D64
  • F19B27
  • G19A31
  • G19C41
  • I19A56 Exp. 06/30/2020
  • d) E19C11
  • F19E33

Distribution

Distribution scope not specified by the agency.

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