Reported Feb 3, 2016 · Terminated

Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL,…

Bausch & Lomb, 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: Bausch & Lomb, Inc. · 8500 Hidden River Pkwy · Tampa, FL · 33637-1014

Is this the product you have?

  • Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637
  • NDC24208-590-64
Lot codes and dates

8 of 8 products

Products covered by this recall
#Product as published
101/2016
2Lot #: 222591, Expiry: 04/2016
3Lot #: 224491, Expiry: 06/2016
4Lot #: 229241, Expiry: 08/2016
5Lot #: 232941, Expiry: 11/2016
6Lot #: 239921, Expiry: 02/2017
7Lot #: 241701, Expiry: 04/2017
8Lot #: 246851, Expiry: 07/2017.
Amount recalled
119,393 Bottles

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 6, 2020 · Data as of Sep 19, 7:02 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.