FDA-Drug2017-12-20Class III
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.
Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Sold states
Nationwide in the USA and Puerto Rico.
Affected count
42,384 bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0108-2018Don't want to check this manually?
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