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.
Reported: December 20, 2017 Initiated: November 28, 2017 #D-0108-2018
Product Description
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 for Recall
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 42,384 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 42,384 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 20, 2017. Severity: Low. Recall number: D-0108-2018.
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