Recall: D-0013-2021
Class II - Potentially Harmful
Class IIClassification
2020-08-24Initiated
TerminatedStatus
Teva Pharmaceuticals USAFirm
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.
Reason
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Distribution
Nationwide in the U.S. and Puerto Rico.
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.