Why it was recalled
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Product description
Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.
Lot numbers, UPCs & expiration codes
Lot #: Q16322M1, Q16323M1, Q16323M2, Q16326M1, Exp 08/19; lot and expiry for individual products within this display are captured in each individual product Code Information
Where it was sold
Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
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-1831-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 26, 2019
- FDA report date
- Aug 28, 2019
- Quantity
- 17,316 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medtech Products, Inc.
Original FDA data
Every field from FDA enforcement report D-1831-2019, exactly as published.
Show all FDA fields
- City
- Tarrytown
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83417
- Address
- 660 White Plains Rd Ste 250
- Code information
- Lot #: Q16322M1, Q16323M1, Q16323M2, Q16326M1, Exp 08/19; lot and expiry for individual products within this display are captured in each individual product Code Information
- Postal code
- 10591-5171
- Report date
- Aug 28, 2019
- Product type
- Drugs
- Recall number
- D-1831-2019
- Classification
- Class II
- Recalling firm
- Medtech Products, Inc.
- Product quantity
- 17,316 bottles
- Termination date
- Mar 10, 2021
- Reason for recall
- CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.
- Distribution pattern
- Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
- Recall initiation date
- Jul 26, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2019