Drug product
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
D-1703-2012
Product summary
- Event
- Event 62911
- Status
- Terminated
- Classification
- Class III
- Quantity
- 31,867 Bottles
- Official record key
drug-enforcement:D-1703-2012
Official wording
Reason: Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Code information: Lot: 3018952, Exp 08/12
Distribution pattern: Nationwide and PR
Derived failure modes
-
Potency or specification failure
Out of specification