Recall Amendment Issued for Eye Drops - MedWaste Management Recall Amendment Issued for Eye Drops - MedWaste Management

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Recall Amendment Issued for Eye Drops

Due to their release of inaccurate information, Kilitch Healthcare India Limited has issued a nationwide press release providing the corrected information. Consumers who utilize the eye drops sold at Walmart, Target, Rite Aide, CVS, and other pharmacies should re-check their medications against the corrected chart below.

In cooperation with the FDA, Kilitch Healthcare India Limited has issued an urgent recall of multiple brands of eye drops. The FDA noted potential safety concerns upon investigation of the manufacturing facility that may lead to serious infections in those who utilize the affected drops.

As of the writing of this notice, no reports of adverse events have yet been received.

SUMMARY

Date of Recall:

Announced: November 15, 2023

Public Notification: November 15, 2023

Amendment Notice: January 22, 2024

Name(s) of Drug:

Multiple eye drops named

See below

Company Name:

Kilitch Healthcare India Limited

Drug Indication:

Dry Eyes

Eye Irritation

 

Product Description

The eye drops are packaged in 10mL and 15mL bottles, with some being delivered in twin packs. Wholesale and retail pharmacy locations nationwide distributed the eye drops.

Reason for Recall

Upon inspection of the manufacturing facility, the FDA noted safety concerns related to unsanitary conditions that could lead to eye drops that are not sterile and may lead to infections.

Impacts

Consumers using the contaminated eye drops are at a risk of developing severe eye infections. These infections can lead to pain or loss of sight and may spread throughout the body, leading to death.

Lot Information

Consumers who use eye drops should compare the information on the list below to that on their eye drop package. If the information matches, read further to determine what actions must be taken to participate in the recall.

 

Product
Product Information
NDC
Retailer
Lubricating Tears Eye Drops, 15mL
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, 15mL
Polyvinyl Alcohol Eye Drops 1.4% w/v
0536-1325-94
Rugby
High Performance Lubricant Eye Drops, 15mL (Single Pack)
Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
11673-522-15
Target
High Performance Lubricant Eye Drops, 15mL (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, Providone 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
Corrected:
11822-4540-5
Rite Aid
LUBRICANT EYE DROPS 15ML (TWIN PACK)
Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
11822-9707-5
Corrected:
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

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

  1. Call your doctor right away. Report the use of the recalled medication.
  2. Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
  3. Consumers with questions may contact Kilitch Healthcare India Limited at regulatory@velocitypharma.com or regulatory@kilitchhealthcare.com..
  4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Kilitch Healthcare India Limited at regulatory@velocitypharma.com or regulatory@kilitchhealthcare.com. Notify them of any recalled batches that have already been sold to consumers.
  3. Notify affected consumers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Kilitch Healthcare India Limited at regulatory@velocitypharma.com or regulatory@kilitchhealthcare.com. Notify them of any recalled batches that have already been shipped to retailers.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

 

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Tammy McKinney, Nurse and Healthcare Writer Byline Image

 

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!

 

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