FDA-Drug2020-09-16Class II
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.
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.
Sold states
Nationwide in the U.S. and Puerto Rico.
Affected count
103,940 bottles
Manufactured in
400 Interpace Pkwy, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0012-2021Don't want to check this manually?
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