Recalls / Class III
Class IIID-0427-2018
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.
- Brand name
- Metformin Hydrochloride
- Generic name
- Metformin Hydrochloride
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDCs
- 65862-008, 65862-009, 65862-010
- FDA application
- ANDA077095
- Affected lot / code info
- Lot#: MTSC17145-A, Exp. July 2021
Why it was recalled
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Recalling firm
- Firm
- Aurobindo Pharma Ltd.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 7476 bottles
- Distribution pattern
- Nationwide within the US
Timeline
- Recall initiated
- 2018-02-02
- FDA classified
- 2018-02-16
- Posted by FDA
- 2018-02-28
- Terminated
- 2021-02-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0427-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.