Why it was recalled
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Product description
Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.
Lot numbers, UPCs & expiration codes
Lot #15522
Where it was sold
Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines
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-1452-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 5, 2016
- FDA report date
- Aug 10, 2016
- Quantity
- 417 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Let's Talk Health, Inc.
Original FDA data
Every field from FDA enforcement report D-1452-2016, exactly as published.
Show all FDA fields
- City
- Chula Vista
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 74605
- Address
- 2411 Fenton St Ste 102
- Code information
- Lot #15522
- Postal code
- 91914-3517
- Report date
- Aug 10, 2016
- Product type
- Drugs
- Recall number
- D-1452-2016
- Classification
- Class II
- Recalling firm
- Let's Talk Health, Inc.
- Product quantity
- 417 bottles
- Termination date
- Jun 6, 2017
- Reason for recall
- Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.
- Distribution pattern
- Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines
- Recall initiation date
- Jul 5, 2016
- Initial firm notification
- Center classification date
- Jul 29, 2016