Class III · Low risk Ongoing
SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour…
Reason Sub-potent Drug
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz…
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, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Class II · Moderate risk Ongoing
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Class II · Moderate risk Ongoing
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Class II · Moderate risk Terminated
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine…
Reason Lack of Assurance of Sterility
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.