D-0427-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 28, 2018
- Initiation Date
- February 2, 2018
- Termination Date
- February 18, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7476 bottles
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
Distribution Pattern
Nationwide within the US
Code Information
Lot#: MTSC17145-A, Exp. July 2021