FDA-Drug2025-04-16Class II

Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC 68462-521-90.

Glenmark Pharmaceuticals Inc., USA
Hazard

CGMP Deviations

Sold states
U.S. Nationwide
Affected count
N/A
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC 68462-521-90.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0328-2025

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