CLASS II Drug recall · Reported 28 Aug 2019 · FDA Enforcement Report
Clear eyes Maximum Redness Relief (Glycerin recalled by Medtech Products
Medtech Products is recalling Clear eyes Maximum Redness Relief (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye, distributed nationwide in the US. The recall was initiated on 26 Jul 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1825-2019
- FDA event ID
- 83417
- Recalling firm
- Medtech Products, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jul 2019
- FDA classified
- 16 Aug 2019
- Reported
- 28 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Eye Drops
Timeline
| 26 Jul 2019 | Recall initiated by company | |
| 16 Aug 2019 | Classified by FDA | +21 days |
| 28 Aug 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 66577 8.
Where it was distributed
Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: 16234, 16247, Exp 08/19; 16286, Exp 10/19; 16314, Exp 11/19
Where was it sold?
Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
13 other products · FDA event 83417This product is part of a recall event; the main page for the event is Clear Eyes Assorted IRC Display recalled by Medtech Products.
More recalls from Medtech Products
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display recalled | Medtech Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clear eyes Maximum Itchy Eye Relief (Glycerin recalled | Medtech Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clear Eyes Redness Relief Hand Pocket Pal Tray Display recalled | Medtech Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clear eyes Redness Relief (Glycerin recalled by Medtech Products | Medtech Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clear eyes Redness Relief (Glycerin recalled by Medtech Products | Medtech Products | Manufacturing (CGMP) Deviations | Nationwide |