CLASS II Drug recall · Reported 24 Oct 2018 · FDA Enforcement Report
Rexall, Extra Moisturizing No Drip Nasal Spray recalled
Product Quest Manufacturing is recalling Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 05%), 48/3/1, distributed nationwide in the US. The recall was initiated on 3 Aug 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0077-2019
- FDA event ID
- 80750
- Recalling firm
- Product Quest Manufacturing, Daytona Beach, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Aug 2018
- FDA classified
- 16 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Nasal Sprays
Timeline
| 3 Aug 2018 | Recall initiated by company | |
| 16 Oct 2018 | Classified by FDA | +74 days |
| 24 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product as listed by the FDA
Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 05%), 48/3/1 recalled?
Yes. Product Quest Manufacturing recalled Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 05%), 48/3/1 on 3 Aug 2018. The recall is Class II and its status is Terminated. Recall number D-0077-2019.
Why was it recalled?
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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