Teva Pharmaceuticals USA recalls Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufac
Recalled December 20, 2017 · FDA recall D-0108-2018 · Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities. · FDA Class III
Units
42,384 bottles
Sold at
Nationwide in the USA and Puerto Rico.
Description
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Product
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →