FDA recall D-0216-2024

Seaway Pharma Inc. · Class II · drug

Product

Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.

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.

Distribution

MI, PA

Key facts

Status
Ongoing
Initiation date
2023-12-28
Report date
2024-01-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Massena, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0216-2024