Drug product
Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-30; c) 5 x 5 gram tubes, NDC 52565-122-07; Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310; Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
D-0693-2022
Product summary
- Event
- Event 89798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 136,960 tubes
- Official record key
drug-enforcement:D-0693-2022
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) 15192, Exp. 2/28/2022; 16278, Exp. 1/31/2023; b) 15124, 15192, Exp. 2/28/2022; 15296, 15336, 15337, 15439, Exp. 3/31/2022; 16278, Exp. 1/31/2023; 16603, 16664, Exp. 3/31/2023;17023, Exp. 6/30/2023; c) 15067, Exp. 2/28/2022; 16664, Exp. 3/31/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Manufacturing or process control
cGMP deviations