Drug product
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60
D-0599-2024
Product summary
- Event
- Event 94854
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 868 tubes
- Official record key
drug-enforcement:D-0599-2024
Official wording
Reason: Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Code information: Lot #, DI2303B, Exp 12/31/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications