Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15
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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