Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product description
QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, UPC 6 35515 99202 3.
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-0049-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 3, 2018
- FDA report date
- Oct 24, 2018
- Quantity
- 4,200 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Product Quest Manufacturing LLC
Original FDA data
Every field from FDA enforcement report D-0049-2019, 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-0049-2019
- Classification
- Class II
- Recalling firm
- Product Quest Manufacturing LLC
- Product quantity
- 4,200 tubes
- 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
- QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, UPC 6 35515 99202 3.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 3, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 16, 2018