Drug Enforcement D-0774-2023

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

Status

Ongoing

Classification

Class II

Report Date

June 7, 2023

Termination Date

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Product Information

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
Product quantity
4,812 units
Reason for recall
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed Nationwide.

Location & Firm

Recalling firm
Denison Pharmaceuticals, LLC
Address
1 Powder Hill Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0774-2023
Event ID
92268
Recall initiation date
May 3, 2023
Center classification date
May 31, 2023
Code info
Lot 8640, Exp: 11/2023
More code info
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