Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.
Recall Number: D-0636-2021
Firm: Teligent Pharma, Inc.
Classification: Class II
Status: Terminated
Report Date: 20210630
Initiation Date: 20210514
Termination Date: 20220822
Reason for Recall
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Product Description
Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.