(WKBN) – Eye drops sold at national retailers including Walmart, Target, CVS and Rite Aid are being recalled after federal investigators found "insanitary conditions," the U.S. Food & Drug Administration announced.
The FDA said using the affected eye drops, which were intended to be sterile, can possibly lead to eye infections or "related harm."
"Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses," the FDA states.
The eye drops, recalled by Kilitch Healthcare India Limited, have expiration dates ranging from November 2023 to September 2025, according to the FDA.
So far, there have been no related incidents of "adverse events" reported to the company.
The following affected products were distributed nationwide under several different labels, according to the FDA.
| Product | Product Information | NDC NO | Retailer / Label |
|---|---|---|---|
| LUBRICATING TEARS EYE DROPS 15 ML | Dextran 70- 0.1% w/v, Glycerin 0.2% w/v, Hypromellose 0.3% w/v | 0536-1282-94 | Rugby |
| Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml | Polyvinyl alcohol Eye Drops 1.4% w/v | 0536-1325-94 | Rugby |
| High Performance Lubricant Eye Drops 15 ml (Single Pack) | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 11673-522-15 | Target |
| High Performance Lubricant Eye Drops 15 ml (Twin Pack) | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 11673-522-30 | Target |
| MULTI-ACTION RELIEF DROPS 15ML | Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops | 11822-2254-3 | Rite Aid |
| LUBRICATING GEL DROPS 10ML | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 11822-4540-3 | Rite Aid |
| LUBRICANT EYE DROPS 10ML (TWIN PACK) | Propylene glycol Eye Drops 0.6% w/v | 11822-4811-3 | Rite Aid |
| LUBRICANT GEL DROPS 15 ML | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 11822-9706-5 | Rite Aid |
| LUBRICANT EYE DROPS 15ML (TWIN PACK) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 11822-9707-5 | Rite Aid |
| Eye Irritation Relief 15 ml | Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops | 70000-0087-1 | Leader |
| Dry Eye Relief 10 ml | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 70000-0088-1 | Leader |
| Dry Eye Relief 15 ml | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 70000-0089-1 | Leader |
| Lubricant Eye Drops 15 ML (Single Pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 70000-0090-1 | Leader |
| Lubricant Eye Drops 15 ML (Twin Pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 70000-0090-2 | Leader |
| Lubricant Eye Drops 10 ml | Propylene glycol Eye Drops 0.6% w/v | 70000-0587-1 | Leader |
| LUBRICANT EYE DROP 10ML (TRIPLE PACK) | Propylene glycol Eye Drops 0.6% w/v | 76168-502-30 | Velocity |
| Lubricant Eye Drops 15 ML (Single Pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 76168-702-15 | CVS |
| Lubricant Eye Drops 15 ML (Twin Pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 76168-702-30 | CVS |
| Lubricant Gel Drops 15 ml (Single Pack) | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 76168-704-15 | CVS |
| Lubricant Gel Drops 15 ml (Twin Pack) | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 76168-704-30 | CVS |
| Multi Action Relief Drops 15 ml | Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops | 76168-706-15 | CVS |
| MILD MODERATE LUBRICATING EYE DROPS 15ML | Polyethylene glycol 400 0.4% w/v | 76168-711-15 | CVS |
| Lubricant Gel Drops 10 ml | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 76168-712-10 | CVS |
| Lubricant Eye Drops 10 ml (Single Pack) | Propylene glycol Eye Drops 0.6% w/v | 76168-714-10 | CVS |
| Lubricant Eye Drops 10 ml (Twin Pack) | Propylene glycol Eye Drops 0.6% w/v | 76168-714-20 | CVS |
| DRY EYE RELIEF 15 ML (TWIN PACK) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 76168-800-30 | Target |
| EQUATE HYDRATION PF LUBRICANT EYE DROPS 10ML | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 79903-168-01 | Walmart |
The FDA says anyone with the affected eye drops should get rid of the products or return them to the place of purchase. Consumers with questions can contact regulatory@velocitypharma.com or regulatory@kilitchhealthcare.com.
Consumers who experience any possible problems with the recalled eye drops should contact their physician or healthcare provider. They can also report adverse reactions or quality problems related to the drops to the FDA's MedWatch Adverse Event Reporting program online.
0 Comments