The Recall Desk
SevereFDA (Drugs)·D-0385-2021·Announced 2021-05-26

Preferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets

Preferred Pharmaceuticals is recalling specific lots of Metformin HCl Extended Release tablets due to the presence of NDMA impurity exceeding safety 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 source text explicitly identifies the recall as Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving significant chemical impurities like NDMA that exceed safety limits.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling 147 bottles (14,700 tablets) of Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR. The product is a prescription-only medication manufactured by Time-Cap Labs Inc. in Farmingdale, NY.

The recall was initiated because the presence of the NDMA impurity was detected in the product, and levels exceeded the Acceptable Daily Intake Limit (ADI) of 96ng/day. This is a Class II recall, indicating a situation where use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.

The affected product was distributed to two physician consignees located in Florida. The specific lot codes involved are C2520W (Exp. 12/31/2021), E0620F (Exp. 12/31/2021), G2020M (Exp. 4/30/2022), and G2720A (Exp. 4/30/2022). Patients and healthcare providers should check their inventory for these specific lot numbers and discontinue use if found.

The recalled product

Product
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
Manufacturer
Preferred Pharmaceuticals, 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 (7)

  • Lot Codes: C2520W
  • Exp.12/31/2021
  • E0620F
  • Exp. 12/31/2021
  • G2020M
  • Exp. 4/30/2022
  • G2720A

Distribution

Distributed in 1 state:

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