Recalls / Class II
Class IID-0217-2024
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
- Brand name
- Oxymetazoline Hydrochloride
- Generic name
- Oxymetazoline Hydrochloride
- Active ingredient
- Oxymetazoline Hydrochloride
- Route
- Nasal
- NDC
- 63868-608
- FDA application
- M012
- Affected lot / code info
- Lot # SE23035, Exp 05/31/2026
Why it was recalled
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.
Recalling firm
- Firm
- Seaway Pharma Inc.
- Manufacturer
- CHAIN DRUG MARKETING ASSOCIATION INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5 County Route 42, N/A, Massena, New York 13662-1569
Distribution
- Quantity
- 8,160 bottles
- Distribution pattern
- MI, PA
Timeline
- Recall initiated
- 2023-12-28
- FDA classified
- 2024-01-04
- Posted by FDA
- 2024-01-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0217-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.