Class III · Low risk
SinuFrin Decongestant
Sub-potent Drug
Premier Value
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-316-03, UPC 8 40986 01516 8.
Affected NDC
68016-0316-03
Compare with the code on your package — it is the most precise check available.
Drug: Oxymetazoline Category: Allergy & Cold Medication
- Recalling firm
- Product Quest Manufacturing LLC
- NDC code
- 68016-316-03
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0047-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Oxymetazoline recalls
See all
Class II · Moderate risk
Quality Choice No Drip Severe Congestion Nasal Pump Mist
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
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist…
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
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution
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
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration
Lack of Assurance of Sterility
Other recalls by Product Quest Manufacturing LLC
All 2018 recalls
Class II · Moderate risk
Family Dollar Saline Nasal Spray 4.25 oz. can
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Finafta Baby
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rexall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rexall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
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