Drug product
Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
D-0686-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 355,672 tubes
- Official record key
drug-enforcement:D-0686-2022
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) 15342, 15343, 16686, Exp. 3/31/2023; b) 15259, 15260, Exp. 3/31/2022; 15282, Exp. 4/30/2022; 15283, Exp. 5/31/2022; 15725, 15745, 15764, Exp. 6/30/2022; 16066, Exp. 10/31/2022
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations