FDA recall D-0294-2022

Product

Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454

Reason for recall

Subpotent

Distribution

nationwide

Key facts

Status

Terminated

Initiation date

2021-12-16

Report date

2021-12-29

Termination date

2022-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0294-2022