Why it was recalled
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
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.
Lot numbers, UPCs & expiration codes
Lot#: MTSC17145-A, Exp. July 2021
Where it was sold
Nationwide within the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0427-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 2, 2018
- FDA report date
- Feb 28, 2018
- Quantity
- 7476 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma Ltd.
Original FDA data
Every field from FDA enforcement report D-0427-2018, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79119
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot#: MTSC17145-A, Exp. July 2021
- Postal code
- 08520-1401
- Report date
- Feb 28, 2018
- Product type
- Drugs
- Recall number
- D-0427-2018
- Classification
- Class III
- Recalling firm
- Aurobindo Pharma Ltd.
- Product quantity
- 7476 bottles
- Termination date
- Feb 18, 2021
- Reason for recall
- Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within the US
- Recall initiation date
- Feb 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 16, 2018