Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65

FDA recall notice · announced February 28, 2018 · Aurobindo Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.

Reason for recall

Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg

Notes

Distribution: Nationwide within the US
Lot/code information: Lot#: MTSC17145-A, Exp. July 2021
Quantity: 7476 bottles
Status: Terminated
Products in this recall event:
- Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited (D-0427-2018)

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