Class II
Terminated
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
- Company
- Akorn, Inc.
- Recall Initiated
- August 13, 2021
- Posted
- September 22, 2021
- Recall Number
- D-0802-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Distribution
USA Nationwide
Lot / Code Info
Lot #: a) 372286, 372289, Exp 1/31/2022, b) 372286, 372289, Exp 1/31/2022
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