FDA Recall D-0217-2024

Seaway Pharma Inc. · Massena, NY

Class II Ongoing 868 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lot # SE23035, Exp 05/31/2026

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 record

Recall number: D-0217-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: MI, PA
Recall initiated: 2023-12-28
Classified by FDA Center: 2024-01-04
FDA published: 2024-01-10
Recalling firm: Seaway Pharma Inc.
Firm location: Massena, NY

Drug identification

Brand name(s): OXYMETAZOLINE HYDROCHLORIDE
Generic name(s): OXYMETAZOLINE HYDROCHLORIDE
Manufacturer(s): CHAIN DRUG MARKETING ASSOCIATION INC
NDC(s): 63868-608
Route(s): NASAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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