Drug product
Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
D-0012-2021
Product summary
- Event
- Event 86285
- Status
- Terminated
- Classification
- Class II
- Quantity
- 103,940 bottles
- Official record key
drug-enforcement:D-0012-2021
Official wording
Reason: CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Code information: Lot #s: a) 30309820A, Exp. 08/2020; 30310000B, 30310001B, Exp. 10/2020; 30310096A Exp. 01/2021; 30310228A, Exp. 03/2021; 30310313A, Exp. 06/2021; b) 30309861A, Exp. 08/2020; 30310335A, Exp. 06/2021.
Distribution pattern: Nationwide in the U.S. and Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP deviations