Recalls / Class II
Class IID-1229-2014
Product
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.
- Affected lot / code info
- Lot 12AN118A, Exp 10/14
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.
Recalling firm
- Firm
- Glenmark Generics Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 2904 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-03-18
- FDA classified
- 2014-04-09
- Posted by FDA
- 2014-04-16
- Terminated
- 2015-01-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1229-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.