Pin-Away Pyrantel Pamoate Recalled for Non-Food-Grade Lubricant Use in Manufacturing
Denison Pharmaceuticals recalls Pin-Away Pyrantel Pamoate pinworm treatment nationwide due to CGMP deviation: non-food-grade lubricant used in the manufacturing mixing vessel.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product with a CGMP manufacturing deviation where no illnesses or injuries have been reported. The use of non-food-grade lubricant in a drug mixing vessel presents a theoretical contamination risk, which meets the High severity criterion.
Plain-English summary
Pin-Away Pyrantel Pamoate (Pyrantel base 50 mg/mL) pinworm treatment is being recalled nationwide. The recall affects 4,812 units distributed under the brand Pin-Away, manufactured by Denison Pharmaceuticals, LLC and distributed by Cara Incorporated.
The recall was initiated due to a manufacturing violation: non-food-grade lubricant was used in the mixing vessel during product preparation. This represents a deviation from Current Good Manufacturing Practice (CGMP) standards for pharmaceutical production.
The affected lot is Lot 8640 with an expiration date of November 2023 (NDC 70309-080-02). Consumers who have purchased this product should cease use and consult their healthcare provider or pharmacist for guidance.
The recalled product
- 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
- Manufacturer
- Denison Pharmaceuticals, LLC
- Category
- Drug — Pinworm Treatment
- Affected units
- 4,812
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 8640
- Exp: 11/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Denison Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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