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.

D-0216-2024

December 28, 2023

Class II

Product summary

Firm: Seaway Pharma Inc.
Event: Event 93708
Status: Ongoing
Classification: Class II
Quantity: 7,992 bottles
Official record key: drug-enforcement:D-0216-2024

Official wording

Reason: 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.

Code information: Lot # SE23034, Exp 05/31/2026

Distribution pattern: MI, PA

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0

microbial contamination