Why it was recalled
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
Product description
Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.
Lot numbers, UPCs & expiration codes
Lot: 173089J Exp. 09/19
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-0074-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 3, 2018
- FDA report date
- Oct 24, 2018
- Quantity
- 16 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Product Quest Manufacturing LLC
Original FDA data
Every field from FDA enforcement report D-0074-2019, 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
- Lot: 173089J Exp. 09/19
- Postal code
- 32117-4416
- Report date
- Oct 24, 2018
- Product type
- Drugs
- Recall number
- D-0074-2019
- Classification
- Class I
- Recalling firm
- Product Quest Manufacturing LLC
- Product quantity
- 16 bottles
- Termination date
- Mar 30, 2021
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 3, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 16, 2018