Updated 1/23/24: Kilitch Healthcare India Limited issued an amendment on the recall, correcting NDC No for the Lubricant Eye Drops 15ML single and twin packs.
Kilitch Healthcare India Limited has issued a voluntary recall for over 20 brands of eye drops at the consumer level, according to a press release from the company released on the FDA website.1
According to Kilitch Healthcare India Limited, the recall is “due to potential safety concerns after FDA investigators found insanitary conditions.”1
The company stated that anyone who used the eyedrops listed in the recall faces a potential risk of eye infections or related harm. Kilitch Healthcare India Limited has not received any reports of adverse events related to this recall.
Products affected by the recall include:1
Lubricating Tears Eye Drops 15 ML
Dextran 70- 0.1% w/v, Glycerin 0.2% w/v, Hypromellose 0.3% w/v
Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml
Polyvinyl alcohol Eye Drops 1.4% w/v
High Performance Lubricant Eye Drops 15 ml (Single Pack)
Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
High Performance Lubricant Eye Drops 15 ml (Twin Pack)
Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
Multi-Action Relief Drops 15ML
Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops
Lubricating Gel Drops 10ML
Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
Lubricant Eye Drops 10ML (Twin pack)
Propylene glycol Eye Drops 0.6% w/v
Lubricant Gel Drops 15 ML
Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
Lubricant Eye Drops 15ML (Twin pack)
Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
Eye Irritation Relief 15 ml
Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops
Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
Lubricant Eye Drops 15 ML (Single Pack)
Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
Lubricant Eye Drops 15 ML (Twin Pack)
Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
Lubricant Eye Drops 10 ml
Propylene glycol Eye Drops 0.6% w/v
Lubricant Eye Drop 10ML (Triple pack)
Propylene glycol Eye Drops 0.6% w/v
Lubricant Eye Drops 15 ML (Single Pack)
Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
Lubricant Eye Drops 15 ML (Twin Pack)
Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
Lubricant Gel Drops 15 ml (Single Pack)
Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
Lubricant Gel Drops 15 ml (Twin Pack)
Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
Multi Action Relief Drops 15 ml
Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops
Mild Moderate Lubricating Eye Drops 15ML
Polyethylene glycol 400 0.4% w/v
Lubricant Gel Drops 10 ml
Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
Lubricant Eye Drops 10 ml (Single Pack)
Propylene glycol Eye Drops 0.6% w/v
Lubricant Eye Drops 10 ml (Twin Pack)
Propylene glycol Eye Drops 0.6% w/v
Dry Eye Relief 15 ML (Twin pack)
Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
Equate Hydration PF Lubricant Eye Drops 10ML
Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
The FDA recently issued a warning letter to Amazon over selling unapproved eye care products, as well as urged customers to avoid certain eye drops due to risk of infections.
The eye drops were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC. Furthermore, according to Kilitch Healthcare India Limited, the company is notifying the distributor who will arrange for the return of all affected items.
References:
Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons. Press Release. Released November 15, 2023. Accessed November 16, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kilitch-healthcare-india-limited-issues-voluntary-nationwide-recall-various-eye-drops-potential?utm_medium=email&utm_source=govdelivery
