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
- Recalling Firm
- Denison Pharmaceuticals, LLC
- 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.
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