Reported Sep 22, 2021 · Terminated
Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL…
Akorn, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- 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 byHi-Tech Pharmacal Co. Inc., Amityville,NY 11701
- Lot codes and dates
Lot #: a) 372286372289Exp 1/31/2022b) 372286372289Exp 1/31/2022
- Amount recalled
- 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289
Where it was sold
- Nationwide
Why it was recalled
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
This product could cause temporary or reversible health problems — stop using it.
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