Teva Pharmaceuticals USA recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle wh
Recalled September 16, 2020 · FDA recall D-0013-2021 · Teva Pharmaceuticals USA
Hazard
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. · FDA Class II
Units
1,467,535 bottles
Sold at
Nationwide in the U.S. and Puerto Rico.
Description
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Product
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.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →