Why it was recalled
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
Product description
Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05.
Lot numbers, UPCs & expiration codes
Lot 12AN118A, Exp 10/14
Where it was sold
Nationwide
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-1229-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 18, 2014
- FDA report date
- Apr 16, 2014
- Quantity
- 2904 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Generics Inc., USA
Original FDA data
Every field from FDA enforcement report D-1229-2014, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67776
- Address
- 750 Corporate Dr
- Code information
- Lot 12AN118A, Exp 10/14
- Postal code
- 07430-2009
- Report date
- Apr 16, 2014
- Product type
- Drugs
- Recall number
- D-1229-2014
- Classification
- Class II
- Recalling firm
- Glenmark Generics Inc., USA
- Product quantity
- 2904 bottles
- Termination date
- Jan 21, 2015
- Reason for recall
- Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 18, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 9, 2014