OXYMETAZOLINE HYDROCHLORIDE Recall D-0216-2024
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.
OXYMETAZOLINE HYDROCHLORIDE Recall D-0216-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0216-2024 |
| Event ID | 93708 |
| Brand | OXYMETAZOLINE HYDROCHLORIDE |
| Generic Name | OXYMETAZOLINE HYDROCHLORIDE |
| Manufacturer | OXYMETAZOLINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | OXYMETAZOLINE HYDROCHLORIDE |
| Drug Route | NASAL |
| Distribution | MI, PA |
| Quantity | 7,992 bottles |
| Recall 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. |
| Drug Classification | Class II |
| Drug Code Info | 20240110 |
| Product NDC | 63868-605 63868-676 |
| Drug UPC | 0635515988439 0635515988477 635515988477 |
| Recall Initiation Date | 20231228 |
| Report Date | 20240110 |
| Classification Date | 20240104 |
| Address | 5 County Route 42 Massena, NY 13662-1569 United States |
| Recalling Firm | Seaway Pharma Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | K89MJ0S5VY |
| Drug Application Number | part341 |
| Structured Product Labeling (SPL ID) | 7abfe9c8-a55e-4b62-84a3-fa5f14aae007 |
| Structured Product Labeling (SPL Set ID) | c7b1f980-9b0d-4f63-a70d-fd366658f863 |
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