Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution — Class II drug recall D-0214-2024
Ongoing recall by Seaway Pharma Inc., reported 2024-01-10, distributed in MI, PA. CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturin
| Recall number | D-0214-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Seaway Pharma Inc., Massena, NY, United States |
| Recall initiated | 2023-12-28 |
| Classified | 2024-01-04 |
| Reported by FDA | 2024-01-10 |
| Distributed | MI, PA |
| Quantity | 7,992 bottles |
| Reason classes | microbial contamination, cgmp |
| UPC / GTIN / UDI-DI | 00635515988439, 00840986035098 |
| NDC | 63868-0607, 63868-0607-01 |
| Lot numbers | SD23032 |
| Expiration dates | 2026-04-30 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0214-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.