Drug Enforcement D-0775-2023

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
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Product quantity
13,968 bottles
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
—

Codes & Dates

Recall number
D-0775-2023
Event ID
92268
Recall initiation date
May 3, 2023
Center classification date
May 31, 2023
Code info
Lot 8639, Exp: 8/2023
More code info
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