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, Manufa…
- Recall date
- November 28, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0108-2018
- FDA classification
- Class III
- Brand / firm
- Teva Pharmaceuticals USA
- Sold / distributed
- Nationwide in the USA and Puerto Rico.
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Class III means the product violates regulations but is not likely to cause harm.
What 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.
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