Warning Issued, Recall Imminent

The FDA has issued a warning letter to ImprimisRX, a drug manufacturing facility in New Jersey. The facility manufactures and distributes ophthalmic treatments in the form of eye drops and injections. Upon inspection, the FDA noted that these products were not stored under sanitary conditions and the drugs may have become contaminated with filth, such as peeling caulking. Also, operators within the facility were seen breaking sterility by not sanitizing their hands. In addition to failure to maintain sterility, compounded drugs were found to be different from their labeled strength.

The FDA is allowing the facility 15 days to come up with a corrective action plan, implement and report it. If the company fails to do so, a massive drug recall will likely follow.

SUMMARY

Date of Warning Notice:

Announced: May 26, 2023

Name(s) of Drug:

Various eye drops and injections

Company Name:

ImprimisRX NJ

Drug Indication:

Eye care

 

About the Products Under Warning

Imprimis RX distributes eye care products to physician’s offices, pharmacies, and patients throughout the US.

Product Name	Packaging
Atropine Sulfate 0.01% PF	5ml multi-use bottle
Atropine Sulfate 0.025%	5ml multi-use bottle
Atropine Sulfate 0.05% PF	5ml multi-use bottle
Bimatoprost 0.01%	5ml multi-use bottle
Brimonidine 0.15% and Dorzolamide 2%	10ml multi-use bottle
Dex-Moxi-Ketor PF	1ml single-use vial
Dex-Moxi PF	1ml single-use vial
Dor PF	10ml multi-use bottle
Epi-Lodi PF	1ml single-use vial
Fortisite (Tobra-Vanc)	7ml multi-use bottle
Klarity Drops PF	10ml multi-use bottle
Klarity-A Drops PF	3.5ml multi-use bottle
Klarity-C Drops PF	5.5ml multi-use bottle
Klarity-CL Drops PF	5ml multi-use bottle
Klarity-L Drops PF	5ml multi-use bottle
MKO Melt	1 each troche
Moxifloxacin 0.5% PF	1ml single-use vial
Mydriatic 3 Single-Use	1ml single-use vial
Mydriatic 4 Multi-Use	5ml multi-use bottle
Phenyl-Lido PF	1ml single-use vial
Pred-Acetate PF	5ml multi-use bottle
Pred-Brom	5ml multi-use bottle
Pred-Gati-Brom Solution, 5ml	5ml multi-use bottle
Pred-Gati-Brom Solution, 8ml	8ml multi-use bottle
Pred-Gati-Brom Suspension, 5ml	5ml multi-use bottle
Pred-Gati-Brom Suspension, 8ml	8ml multi-use bottle
Pred-Moxi-Brom Solution, 8ml	8ml multi-use bottle
Pred-Moxi-Brom Suspension, 5ml	5ml multi-use bottle
Pred-Moxi-Brom Suspension, 8ml	8ml multi-use bottle
Pred-Moxi-Nepaf, 5ml	5ml multi-use bottle
Pred-Moxi-Nepaf, 8ml	8ml multi-use bottle
Pred-Moxi	5ml multi-use bottle
Pred-Nepaf	5ml multi-use bottle
Tim-Bim PF	5ml multi-use bottle
Tim-Brim-Dor-Bim PF	5ml multi-use bottle
Tim-Dor-Bim PF	5ml multi-use bottle
Tri-Moxi+ PF	0.6ml single-use bottle

 

Reason for Notice

Unsanitary storage conditions

Lack of sterility

Mis-labeling of drug dosages

Impacts

Consumers who utilize these medications are at risk of adverse reactions related to mis-dosing and eye damage as a result of contamination. While the FDA is not recommending discontinuation of the drugs at this time, consumers should monitor Med Waste Management for future drug recalls related to the investigation.

Is your medication manufactured by ImprimisRX and included in the warning? Here’s what you should do.

Consumers

1. At this time, the medications have not been recalled and there is no need for further action. If you have concerns regarding medication usage, contact your physician or pharmacist directly.
2. If you use any medications from this company, monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
3. 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.
4. If your physician advises you to dispose of the medication, contact MedWaste Management for information and/or assistance with disposal.

Retailer

1. Track drug recalls through the FDA or Med Waste Management websites.
2. Notify affected consumers if a recall is announced.
3. Contact MedWaste Management for information and/or assistance with disposing of medications if necessary.

 

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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!