Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0
Reported: January 10, 2024 Initiated: December 28, 2023 #D-0217-2024
Product Description
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0
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.
Details
- Recalling Firm
- Seaway Pharma Inc.
- Units Affected
- 8,160 bottles
- Distribution
- MI, PA
- Location
- Massena, NY
Frequently Asked Questions
What product was recalled? ▼
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0. Recalled by Seaway Pharma Inc.. Units affected: 8,160 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 10, 2024. Severity: Moderate. Recall number: D-0217-2024.
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