Recall: D-0427-2018

Class III - Minor Violations

Class IIIClassification

2018-02-02Initiated

TerminatedStatus

Aurobindo Pharma Ltd.Firm

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

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

Distribution

Nationwide within the US

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.