FDAClass IIJune 7, 2023

Pin-away Pyrental Pamoate recall: CGMP Deviations

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

Why was Pin-away Pyrental Pamoate recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 8640, Exp: 11/2023

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
Recalling firm
Denison Pharmaceuticals, LLC
Quantity
4,812 units
Distribution
Product was distributed Nationwide.
Recall date
June 7, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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