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.
HuMist Saline Nasal Mist 1.5 FL OZ
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
HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .
- Recalling firm
- Product Quest Manufacturing LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0043-2019 · 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 recalls by Product Quest Manufacturing LLC
All 2018 recalls
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CGMP Deviations: products manufactured under conditions that could impact its product quality.
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All cgmp deviation recalls
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Progesterone 100 mg SR capsules
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