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 1 01/2016 2 Lot #: 222591, Expiry: 04/2016 3 Lot #: 224491, Expiry: 06/2016 4 Lot #: 229241, Expiry: 08/2016 5 Lot #: 232941, Expiry: 11/2016 6 Lot #: 239921, Expiry: 02/2017 7 Lot #: 241701, Expiry: 04/2017 8 Lot #: 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.
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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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