PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: June 7, 2023 Initiated: May 3, 2023 #D-0774-2023

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.

Details

Units Affected
4,812 units
Distribution
Product was distributed Nationwide.
Location
Lincoln, RI

Frequently Asked Questions

What product was recalled?
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. Recalled by Denison Pharmaceuticals, LLC. Units affected: 4,812 units.
Why was this product recalled?
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 7, 2023. Severity: Moderate. Recall number: D-0774-2023.