Recall: D-0108-2018

Class III - Minor Violations

Class IIIClassification

2017-11-28Initiated

TerminatedStatus

Teva Pharmaceuticals USAFirm

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.

Reason

Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.

Distribution

Nationwide in the USA 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.