D-0774-2023 Class II Ongoing

Recalled by Denison Pharmaceuticals, LLC — Lincoln, RI

Recall Details

Product Type
Drugs
Report Date
June 7, 2023
Initiation Date
May 3, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,812 units

Product Description

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 Pattern

Product was distributed Nationwide.

Code Information

Lot 8640, Exp: 11/2023