Betamethasone dipropionate .5 mg/g

LEO PHARMA INC

Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.

Teligent Pharma, Inc.

Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing

Well Care Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Teligent Pharma, Inc.

Failed Impurities/Degradation Specifications

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

Teligent Pharma, Inc.

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

Glenmark Pharmaceuticals Inc., USA

Temperature Abuse: Complaints received of liquidy texture.

Teligent Pharma, Inc.

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

McKesson Corporation dba McKesson Drug Company

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.