Product: Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Reason for recall: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated: 20220315
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated