Recalls / Class II
Class IID-1409-2012
Product
Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10
- Affected lot / code info
- Lot #TE1Y261, Exp, 12/2013
Why it was recalled
Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 2,268 bottles
- Distribution pattern
- Ohio
Timeline
- Recall initiated
- 2012-05-16
- FDA classified
- 2012-07-05
- Posted by FDA
- 2012-07-11
- Terminated
- 2013-03-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1409-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.