Drug product
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.
D-1566-2020
Product summary
- Event
- Event 86285
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38,487 bottles
- Official record key
drug-enforcement:D-1566-2020
Official wording
Reason: Sub-Potent Drug: Out of specification test results for potency (below specification).
Code information: Lot #: 30310638A, Exp. 02/2022
Distribution pattern: Nationwide in the U.S. and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out of specification