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Teligent Pharma, Inc. recalls Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, N

Recalled January 5, 2022 · FDA recall D-0297-2022 · Teligent Pharma

Hazard
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing · FDA Class II
Units
3,792 bottles
Sold at
Distributed Nationwide in the USA

Description

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

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

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Teligent Pharma, Inc. recalls Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, N | RecallWatchUSA