D-0216-2024 Class II Ongoing
FDA drug recall D-0216-2024 was initiated by Seaway Pharma Inc. on December 28, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 7,992 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 10, 2024
- Initiation Date
- December 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,992 bottles
Product Description
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 Pattern
MI, PA
Code Information
Lot # SE23034, Exp 05/31/2026