Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottl
Summary
The FDA issued a Class II for Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL b by Akorn, Inc.. Reason: Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product..
Details
Source
Drug Recall
External ID
D-0802-2021
Action Date
2021-09-22
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: a) 372286, 372289, Exp 1/31/2022, b) 372286, 372289, Exp 1/31/2022
Quantity Affected: 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289
Reason for Recall
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-13
Company
Lake Forest, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 25 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Akorn, Inc. has 130 FDA actions in our database, including 130 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Akorn, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Akorn, Inc. have FDA actions?
Akorn, Inc. has 130 FDA actions in our database, including 130 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0802-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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