Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical 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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability…
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
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