Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product description
Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 7 .
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-0039-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 3, 2018
- FDA report date
- Oct 24, 2018
- Quantity
- 5040 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Product Quest Manufacturing LLC
Original FDA data
Every field from FDA enforcement report D-0039-2019, 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-0039-2019
- Classification
- Class II
- Recalling firm
- Product Quest Manufacturing LLC
- Product quantity
- 5040 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
- Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 7 .
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 3, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 16, 2018