News|Articles|January 23, 2024
Kilitch Healthcare India Limited issues voluntary recall of various eye drops due to potential safety risk
Author(s)Martin David Harp
The recall is “due to potential safety concerns after FDA investigators found insanitary conditions.”
Advertisement
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
Product
Product Information
NDC Number
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
11822-4540-5
Rite Aid
Lubricant Eye Drops 15ML (Twin pack)
Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
11822-4811-5
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 recently issued a
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
Newsletter
Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.
Advertisement
Related Content
Advertisement
Latest CME
Advertisement
Advertisement
Trending on Ophthalmology Times - Clinical Insights for Eye Specialists
1
Increasing the knowledge base of GA is key to individualizing patient therapy
2
EYDENZELT, Celltrion’s biosimilar referencing EYLEA, approved by FDA
3
REGENXBIO completes enrollment in ATMOSPHERE and ASCENT trials of sura-vec in wet AMD
4
Q&A: Inder Paul Singh, MD, explores technician empowerment via the Academy Technician Training Platform
5
.png "Optometry Times"){kind=logo}
