FDA recall D-0108-2018

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 for recall

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

Distribution

Nationwide in the USA and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2017-11-28

Report date

2017-12-20

Termination date

2018-07-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0108-2018