FDAFDA · Food and drugs·Recall number D-0108-2018
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.
Published December 20, 2017 · Recall initiated: November 28, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PENICILLIN V POTASSIUM
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide in the USA and Puerto Rico.
- UPC
- 0300934125733
- Lot
- Lot # 35433115A, Exp 01/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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