D-0297-2022 Class II Terminated
FDA drug recall D-0297-2022 was initiated by Teligent Pharma, Inc. on August 23, 2021 and is designated Class II. 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 The recall status is terminated (terminated August 16, 2024). Affected quantity: 3,792 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 5, 2022
- Initiation Date
- August 23, 2021
- Termination Date
- August 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,792 bottles
Product Description
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 Pattern
Distributed Nationwide in the USA
Code Information
Lot # 16569, Exp 9/2022