Drug 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
D-0774-2023
Product summary
- Event
- Event 92268
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,812 units
- Official record key
drug-enforcement:D-0774-2023
Official wording
Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Code information: Lot 8640, Exp: 11/2023
Distribution pattern: Product was distributed Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations