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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Westlab Pharmacy, Inc. dba Westlab Pharmacy: Alprostadil and Eye Drops Recalled for Formulation and Process Control Issues

Agency Publication Date: October 24, 2018
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Summary

Westlab Pharmacy, Inc. is recalling approximately 309 units of Alprostadil 500 mcg/mL Injectable, ADAA Cataract Drops, and Cyclosporine 1% Human Eye Drops. The recall was initiated because of incorrect product formulation and a lack of necessary process controls during manufacturing. These issues mean the medications may not contain the correct amount of active ingredients or may have been produced in a way that doesn't guarantee safety. If you are using these products, contact your healthcare provider or pharmacist immediately to discuss your treatment and how to return the affected items for a refund.

Risk

Incorrect drug formulation can lead to ineffective treatment or serious adverse reactions due to improper dosing. A lack of manufacturing process controls increases the risk that sterile products like injectables and eye drops could be contaminated, potentially causing infections or severe irritation.

What You Should Do

  1. Check your prescription labels and packaging to see if you have Alprostadil 500 mcg/mL Injectable, ADAA Cataract Drops, or Cyclosporine 1% Human Eye Drops from Westlab Pharmacy.
  2. Verify the lot numbers and expiration dates: for Alprostadil, look for lot 03192018@42 (Discard after 9/15/2018); for ADAA Cataract Drops, look for lot 06182018@30 (Exp. 08/28/2018); and for Cyclosporine, look for lot 07262018@7 (Exp. 08/25/2018).
  3. Contact your healthcare provider or pharmacist for guidance on your treatment and to report any side effects.
  4. Return any unused product to Westlab Pharmacy at 4410 W Newberry Rd Ste A5, Gainesville, FL 32607, for a refund.
  5. Contact the manufacturer, Westlab Pharmacy, Inc., for further instructions regarding this recall.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions or concerns.

Your Remedy Options

๐Ÿ’ฐFull Refund

Product return and pharmacist consultation.

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

Affected Products

Product: Alprostadil 500 mcg/mL Injectable (80 syringes)
Model:
NDC 10002-7335-00
Lot Numbers:
03192018@42 (Discard after 9/15/2018)
03192018
Date Ranges: Discard after 9/15/2018
Product: ADAA Cataract Drops, 1x 1cc syringe (222 syringes)
Model:
NDC 10002-2579-05
Lot Numbers:
06182018@30 (Exp. 08/28/2018)
06182018
Date Ranges: Exp. 08/28/2018
Product: Cyclosporine 1% Human Eye Drops (7 droptainers)
Model:
NDC 10002-2776-92
Lot Numbers:
07262018@7 (Exp. 08/25/2018)
07262018
Date Ranges: Exp. 08/25/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80838
Status: Resolved
Manufacturer: Westlab Pharmacy, Inc. dba Westlab Pharmacy
Sold By: Westlab Pharmacy; specialty pharmacy
Manufactured In: United States
Units Affected: 3 products (80 syringes; 222 syringes; 7 droptainers)
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.

Find an Attorney

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.