(WKBN) – The Food & Drug Administration announced that eye drops that are being sold at multiple national retailers are being recalled due to potential safety concerns after FDA investigators found insanitary conditions.
The recalled eye drops have expiration dates ranging from November 2023 to September 2025.
The FDA states that using the eye drops leads to a potential risk of eye infections or related harm, because they are intended to be sterile. The FDA states that ophthalmic drug products pose a potentially heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.
To date, Kilitch Healthcare India Limited, the company that produced the eye drops, has not received any reports of adverse events related to this recall.
Eye drops at the following retailers have been recalled:
| 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 that these products were distributed nationwide to wholesalers, retailers and via the product distributor, Velocity Pharma LLC.
According to an alert from the FDA, consumers, distributors and retailers that use the eye drops should get rid of the products or return the products to the place they were purchased.
Consumers with questions regarding this recall can contact regulatory@velocitypharma.com or regulatory@kilitchhealthcare.com.
Consumers should contact their physician or healthcare provider if they have experienced any problems that could be related to taking or using the eye drops.
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Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online.
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