Why it was recalled
CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.
Product description
Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No. 10828-002-06, Cas No: 1115-70-4
Lot numbers, UPCs & expiration codes
Lot #: DMFH-366/11, DMFH-367/11, DMFH-368/11, DMFH-369/11, DMFH-370/11, DMFH-371/11, DMFH-372/11, DMFH-373/11, DMFH-374/11, DMFH-375/11, DMFH-376/11, DMFH-393/11, DMFH-394/11, DMFH-395/11, DMFH-396/11, DMFH-397/11, DMFH-399/11, DMFH-400/11, DMFH-401/11, DMFH-402/11, DMFH-403/11, DMFH-404/11, DMFH-405/11, DMFH-406/11
Where it was sold
MO
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-406-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 7, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 27,000 kilos (1080 drums)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Betachem, Inc.
Original FDA data
Every field from FDA enforcement report D-406-2014, exactly as published.
Show all FDA fields
- City
- Upper Saddle River
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67155
- Address
- 58 Ware Rd
- Code information
- Lot #: DMFH-366/11, DMFH-367/11, DMFH-368/11, DMFH-369/11, DMFH-370/11, DMFH-371/11, DMFH-372/11, DMFH-373/11, DMFH-374/11, DMFH-375/11, DMFH-376/11, DMFH-393/11, DMFH-394/11, DMFH-395/11, DMFH-396/11, DMFH-397/11, DMFH-399/11, DMFH-400/11, DMFH-401/11, DMFH-402/11, DMFH-403/11, DMFH-404/11, DMFH-405/11, DMFH-406/11
- Postal code
- 07458-1922
- Report date
- Jan 22, 2014
- Product type
- Drugs
- Recall number
- D-406-2014
- Classification
- Class II
- Recalling firm
- Betachem, Inc.
- Product quantity
- 27,000 kilos (1080 drums)
- Termination date
- Aug 7, 2017
- Reason for recall
- CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No. 10828-002-06, Cas No: 1115-70-4
- Distribution pattern
- MO
- Recall initiation date
- Oct 7, 2013
- Initial firm notification
- Center classification date
- Jan 10, 2014