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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

ImprimisRx NJ: Subpotent Timolol, Latanoprost, and Dorzolamide Ophthalmic Drops

Agency Publication Date: July 31, 2019
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Summary

ImprimisRx NJ is recalling 651 bottles of Timolol-Latanoprost and Timolol-Dorzolamide-Latanoprost preservative-free ophthalmic drops. These prescription eye drops, used primarily for treating glaucoma and ocular hypertension, were found to be subpotent, meaning they do not contain the full strength of the active ingredients required. Approximately 405 bottles of the two-drug combo and 246 bottles of the three-drug combo are affected. Consumers who use these medications should contact their healthcare provider or pharmacist for guidance, as the reduced strength may not effectively manage eye pressure.

Risk

The subpotent nature of these eye drops means the medication may not be effective in reducing intraocular pressure as intended. This could lead to poorly controlled glaucoma or ocular hypertension, potentially resulting in vision loss if the condition is not properly managed.

What You Should Do

  1. Identify if you have Timolol-Latanoprost P-F (0.5/0.005%) 5mL bottles by checking the label for Lot Numbers 01252019@1 (Exp. 07/21/2019), 03182019@7 (Exp. 09/7/2019), or 05092019@2 (Exp. 11/2/2019).
  2. Identify if you have Timolol-Dorzolamide-Latanoprost P-F (0.5/2.0/0.005%) 5mL bottles by checking the label for Lot Numbers 03132019@2 (Exp. 09/17/2019) or 05102019@2 (Exp. 11/02/2019).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription to ensure your eye pressure remains controlled.
  4. Return any unused product to the pharmacy where it was purchased for a refund and further instructions.
  5. Contact ImprimisRx NJ at (844) 446-6979 for more information regarding this recall.
  6. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops (5mL)
Model:
Recall #: D-1578-2019
Lot Numbers:
01252019@1 (Exp. 07/21/2019)
03182019@7 (Exp. 09/7/2019)
05092019@2 (Exp. 11/2/2019)
Date Ranges: 07/21/2019, 09/7/2019, 11/2/2019
Product: Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops (5mL)
Model:
Recall #: D-1579-2019
Lot Numbers:
03132019@2 (Exp. 09/17/2019)
05102019@2 (Exp. 11/02/2019)
Date Ranges: 09/17/2019, 11/02/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83353
Status: Resolved
Manufacturer: ImprimisRx NJ
Sold By: ImprimisRx NJ
Manufactured In: United States
Units Affected: 2 products (405 bottles; 246 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.