Drug product
Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12
D-1094-2017
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 77800
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1172 cartons (23440 tablets)
- Official record key
drug-enforcement:D-1094-2017
Official wording
Reason: Failed impurities/degradation specifications: Out of specification for a related compound C.
Code information: Lot #: 16933, Exp 07/2018; 17054, Exp 08/2018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification