Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Recall Number: D-0013-2021
Firm: Teva Pharmaceuticals USA
Classification: Class II
Status: Terminated
Report Date: 20200916
Initiation Date: 20200824
Termination Date: 20211216
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.
Product Description
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.