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.

Recall Number: D-0012-2021

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 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.