CLASS II ONGOING Drug recall · Reported 7 Jun 2023 · FDA Enforcement Report
Pin-Away Pyrental Pamoate (Pyrantel base 50 mg / mL) recalled
Denison Pharmaceuticals is recalling Pin-Away Pyrental Pamoate (Pyrantel base 50 mg / mL) Pinworm Treatment, distributed nationwide in the US. The recall was initiated on 3 May 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0774-2023
- FDA event ID
- 92268
- Recalling firm
- Denison Pharmaceuticals, Lincoln, RI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 May 2023
- FDA classified
- 31 May 2023
- Reported
- 7 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 3 May 2023 | Recall initiated by company | |
| 31 May 2023 | Classified by FDA | +28 days |
| 7 Jun 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Product as listed by the FDA
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
Where it was distributed
Product was distributed Nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Which lots are affected?
Lot 8640, Exp: 11/2023
Where was it sold?
Product was distributed Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 92268| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Safe tussin PM, Night Time Cough Relief recalled | Denison Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine recalled | Denison Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Safe tussin DM, DAY TIME Cough Relief recalled | Denison Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Denison Pharmaceuticals
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel recalledZapzyt Acne Treatment Gel | Denison Pharmaceuticals | Benzene | Nationwide |
| Drug | CLASS III | Kids' Cough and Chest Congestion (Dextromethorphan HBr recalledMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack | Denison Pharmaceuticals | Packaging Defects | RI |
| Drug | CLASS III | Adult Cough and Chest Congestion recalled by Denison PharmaceuticalsMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack | Denison Pharmaceuticals | Packaging Defects | RI |
| Drug | CLASS II | Little Remedies Gas Relief Drops (Simethicone/Antigas) recalledLittle Remedies | Denison Pharmaceuticals | Sterility | RI |
| Drug | CLASS II | Safe tussin DM, DAY TIME Cough Relief recalled | Denison Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |