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Recall Enforment Report D-0338-2021

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Teligent Pharma, Inc., originally initiated on 02-02-2021 for the product Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15 The product was recalled due to failed impurities/ degradation specifications - oos for know impurity betamethasone 17- propionate.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0338-202102-02-202105-05-2021Class III104,784 tubesBetamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.Terminated
D-0340-202102-02-202105-05-2021Class IIIN/ABetamethasone 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 63739-996-15Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.Terminated
D-0339-202102-02-202105-05-2021Class III79,416 tubesBetamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.Terminated