Class III · Low risk Ongoing
SinuFrin Decongestant
Reason Sub-potent Drug
Maximum Strength No Drip Nasal Spray
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
What was recalled
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6319-1
- Recalling firm
- Perrigo Company PLC
- NDC code
- 11822-6319-1
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0621-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Oxymetazoline recalls
See all
Class II · Moderate risk Ongoing
Quality Choice No Drip Severe Congestion Nasal Pump Mist
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.
Class II · Moderate risk Ongoing
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist…
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.
Class II · Moderate risk Ongoing
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution
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.
Class II · Moderate risk Terminated
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for…
Reason Lack of Assurance of Sterility
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