FDA recall D-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

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-0217-2024