Betamethasone Dipropionate recall: Impurity Out of Spec
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
Why was Betamethasone Dipropionate recalled?
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) 372286, 372289, Exp 1/31/2022, b) 372286, 372289, Exp 1/31/2022
- 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
- Recalling firm
- Akorn, Inc.
- Quantity
- 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289
- Distribution
- USA Nationwide
- Recall date
- September 22, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)