Drug product
Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
D-0692-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,497 bottles
- Official record key
drug-enforcement:D-0692-2022
Official wording
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Code information: Batch: a) 16293, Exp. 1/31/2023; 16436, 16451, Exp. 2/28/2023; b) 15105, Exp. 2/28/2022; 15290, 15291, 15292, Exp. 3/31/2022; 16293, Exp. 1/31/2023; 16436, 16451, 16472, Exp. 2/28/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations