FDA-Drug2021-05-05Class III

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

Teligent Pharma, Inc.
Hazard

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

Sold states
USA Nationwide
Affected count
79,416 tubes
Manufactured in
105 Lincoln Avenue, N/A, Buena, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0339-2021

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