Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot # 16569, Exp 9/2022
Why it was recalled
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, Buena, New Jersey 08310
Distribution
- Quantity
- 3,792 bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-08-23
- FDA classified
- 2021-12-28
- Posted by FDA
- 2022-01-05
- Terminated
- 2024-08-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0297-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.