Drug product
Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
D-0802-2021
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 88488
- Status
- Terminated
- Classification
- Class II
- Quantity
- 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289
- Official record key
drug-enforcement:D-0802-2021
Official wording
Reason: Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Code information: Lot #: a) 372286, 372289, Exp 1/31/2022, b) 372286, 372289, Exp 1/31/2022
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification