The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1364-2020·Announced 2020-07-08

Preferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets Due to NDMA

Preferred Pharmaceuticals is recalling 144 bottles of Metformin HCl Extended Release Tablets, 500 mg, because FDA analysis detected N-Nitrosodimethylamine (NDMA) levels exceeding the Acceptable Daily Intake Limit.

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, particularly given the detection of a carcinogenic impurity (NDMA) exceeding safety limits.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling 144 bottles of Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100. The product was manufactured by Time-Cap, Labs Inc. in Farmingdale, NY, and distributed by Preferred Pharmaceuticals in Anaheim, CA. The specific NDC is 68788-6932-01.

The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. This constitutes a Current Good Manufacturing Practice (CGMP) deviation. The affected lots include codes J0119M, K1419L, K2719J, and A0220H, all with an expiration date of 12/2020.

The product was distributed to two medical clinics located in Florida. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
144

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 (5)

  • J0119M
  • K1419L
  • K2719J
  • A0220H
  • Exp. Date 12/2020

Distribution

Distributed in 1 state:

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