Drug product
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.
D-0698-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 112,769 bottles
- Official record key
drug-enforcement:D-0698-2022
Official wording
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Code information: Batch: 14796, Exp. 12/31/2022; 14797, Exp. 1/31/2023; 14534, 15571, 15572, Exp. 4/30/2023; 15746, 15756, Exp. 6/30/2023; 15982, Exp. 9/30/2023; 16043, 16144, 16149, Exp. 10/31/2023; 16433, 16434, Exp. 2/29/2024; 16656, 16679, Exp. 3/31/2024; 16784, Exp. 5/31/2024
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations