PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: February 28, 2018 Initiated: February 2, 2018 #D-0427-2018

Product Description

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

Details

Recalling Firm
Aurobindo Pharma Ltd.
Units Affected
7476 bottles
Distribution
Nationwide within the US
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Aurobindo Pharma Ltd.. Units affected: 7476 bottles.
Why was this product recalled?
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Which agency issued this recall?
This recall was issued by the FDA Drug on February 28, 2018. Severity: Low. Recall number: D-0427-2018.