Reported Feb 13, 2019 · Terminated

Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles,…

Lupin Pharmaceuticals Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174

Is this the product you have?

  • Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only
  • Manufactured byLupin Limited Pithampur (M.P.) 454 775, INDIA
Lot codes and dates
    • a) H804506 Exp. 06/2020
    • 803555 Exp. 04/2020
    • H805394
    • Exp. 08/2020 b) H804112 Exp. 05/2020
    • H803220 Exp. 03/2020
Amount recalled
9,930 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 22, 2020 · Data as of Sep 19, 7:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.