Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmace

FDA recall notice · announced November 11, 2020 · Denton Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131

Reason for recall

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Notes

Distribution: Indiana - Nationwide.
Lot/code information: a) 30 count: N107051905, exp 10/31/2020; N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/2020; N107052001 6/30/2021; N107052010, N107052008, N107052004, exp 9/30/2021; c) 90 count: C107051908, exp 10/31/2020, C107052002, C107051909 exp 6/30/2021, C107052001, exp 12/31/2020, C107052004, N107052006, N107052007, N107052009, N107052011, N107052012 exp 9/30/2021; d) 120 count: C107051907, N107051904, N107051906 exp 10/31/2020 C107051910, exp 6/30/2021; C107052003, C107052005, N107052003 exp 9/30/2021
Quantity: a) 684; b) 432; c) 3668; d) 2029 bottles
Status: Ongoing
Products in this recall event:
- Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30 (D-0056-2021)
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx On (D-0057-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.