Drug product
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
D-0610-2017
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 76617
- Status
- Terminated
- Classification
- Class II
- Quantity
- 116 cartons
- Official record key
drug-enforcement:D-0610-2017
Official wording
Reason: Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Code information: Lot #15152, Exp. 02/2018
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.