Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product description
Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL OZ (44 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 58487 2.
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0059-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 3, 2018
- FDA report date
- Oct 24, 2018
- Quantity
- 30,096 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Product Quest Manufacturing LLC
Original FDA data
Every field from FDA enforcement report D-0059-2019, exactly as published.
Show all FDA fields
- City
- Daytona Beach
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 80750
- Address
- 330 Carswell Ave
- Code information
- All lots remaining within expiry.
- Postal code
- 32117-4416
- Report date
- Oct 24, 2018
- Product type
- Drugs
- Recall number
- D-0059-2019
- Classification
- Class II
- Recalling firm
- Product Quest Manufacturing LLC
- Product quantity
- 30,096 bottles
- Termination date
- Mar 30, 2021
- Reason for recall
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL OZ (44 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 58487 2.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 3, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 16, 2018