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

FDA recall notice · announced May 5, 2021 · Teligent Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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

Reason for recall

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

Notes

Distribution: USA Nationwide
Lot/code information: Lot #: 14297, Exp 9/2021; 15372, Exp 3/2022; 15841, Exp 8/2022
Quantity: 104,784 tubes
Status: Terminated
Products in this recall event:
- Betamethasone 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 Pac (D-0340-2021)
- Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51 (D-0339-2021)
- 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 (D-0338-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.