FDA recall D-0297-2022

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

Reason for recall

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

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-08-23

Report date

2022-01-05

Termination date

2024-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buena, NJ, United States

Primary source

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