D-1229-2014 Class II Terminated
FDA drug recall D-1229-2014 was initiated by Glenmark Generics Inc., USA on March 18, 2014 and is designated Class II. 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 Ta… The recall status is terminated (terminated January 21, 2015). Affected quantity: 2904 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 16, 2014
- Initiation Date
- March 18, 2014
- Termination Date
- January 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2904 bottles
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.
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.
Distribution Pattern
Nationwide
Code Information
Lot 12AN118A, Exp 10/14