FDA Drug recall D-0214-2024
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed b…
- FDA Drug
- Class II
- ongoing
- Published 2024-01-10
On 2024-01-10 the FDA classified a Class II recall of Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed b… 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-0214-2024 |
| 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
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.
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 | 635515988439 |
|---|---|
| upc | 840986035098 |
| ndc | 63868-607-01 |
| code_info | Lot # SD23032, Exp 04/30/2026 |
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-0214-2024%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.