Product: Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, 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