Drug product
Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.
D-1370-2015
Product summary
- Event
- Event 71845
- Status
- Terminated
- Classification
- Class III
- Quantity
- 16,320 Bottles
- Official record key
drug-enforcement:D-1370-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
Code information: Lot #: C4177-14965, Expiry: February 2016; Lot #: C4178-14965, Expiry: February 2016.
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification