FDA recall D-0774-2023

Denison Pharmaceuticals, LLC · Class II · drug

Product

Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02

Reason for recall

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Distribution

Product was distributed Nationwide.

Key facts

Status: Ongoing
Initiation date: 2023-05-03
Report date: 2023-06-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lincoln, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0774-2023