Drug Enforcement D-0217-2024

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

Status

Ongoing

Classification

Class II

Report Date

January 10, 2024

Termination Date

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Product Information

Product description
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0
Product quantity
8,160 bottles
Reason for recall
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
MI, PA

Location & Firm

Recalling firm
Seaway Pharma Inc.
Address
5 County Route 42, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0217-2024
Event ID
93708
Recall initiation date
December 28, 2023
Center classification date
January 4, 2024
Code info
Lot # SE23035, Exp 05/31/2026
More code info
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