Recalls / Class II
Class IID-0802-2021
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
- Affected lot / code info
- Lot #: a) 372286, 372289, Exp 1/31/2022, b) 372286, 372289, Exp 1/31/2022
Why it was recalled
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2021-08-13
- FDA classified
- 2021-09-16
- Posted by FDA
- 2021-09-22
- Terminated
- 2022-08-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0802-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.