FDA-Drug2022-01-05Class II

Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29

Teligent Pharma, Inc.
Hazard

Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing

Sold states
Distributed Nationwide in the USA
Affected count
3,792 bottles
Manufactured in
105 Lincoln Avenue, Buena, NJ, United States
Products
Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0297-2022

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