FDA Drug recall D-0216-2024
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bo…
- FDA Drug
- Class II
- ongoing
- Published 2024-01-10
On 2024-01-10 the FDA classified a Class II recall of Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bo… by Seaway Pharma, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0216-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-28 |
| Published | 2024-01-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Seaway Pharma |
| Distribution | MI, PA |
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
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.
Identifiers
| upc | 635515988477 |
|---|---|
| ndc | 63868-605-01 |
| ndc | 63868-676-01 |
| code_info | Lot # SE23034, Exp 05/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0216-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.