D-0012-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 16, 2020
- Initiation Date
- August 24, 2020
- Termination Date
- December 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 103,940 bottles
Product Description
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.
Reason for Recall
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Distribution Pattern
Nationwide in the U.S. and Puerto Rico.
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.