Recalls / Class III
Class IIID-1703-2012
Product
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
- Affected lot / code info
- Lot: 3018952, Exp 08/12
Why it was recalled
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 31,867 Bottles
- Distribution pattern
- Nationwide and PR
Timeline
- Recall initiated
- 2012-06-28
- FDA classified
- 2012-09-28
- Posted by FDA
- 2012-10-10
- Terminated
- 2013-03-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1703-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.