Drug product
Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
D-1469-2016
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 74794
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,045 units
- Official record key
drug-enforcement:D-1469-2016
Official wording
Reason: Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Code information: Lot#: 1967800, Exp10/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification