Kilitch Healthcare India Limited issues voluntary recall of various eye drops due to potential safety risk

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Article

The recall is “due to potential safety concerns after FDA investigators found insanitary conditions.”

 (Image Credit: AdobeStock)

(Image Credit: AdobeStock)

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 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:
  1. 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
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