Agency classClass IIOur severity:Severe FDA (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.

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, 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…
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Category: Drug — Prescription Medication
Hazard: ndma-impurity
carcinogen-exposure
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.

Same manufacturer · PD-Rx Pharmaceuticals, Inc.

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Same hazard · ndma impurity