Recalls / Class III
Class IIID-0646-2016
Product
Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.
- Brand name
- Tropicamide
- Generic name
- Tropicamide
- Active ingredient
- Tropicamide
- Route
- Ophthalmic
- NDCs
- 24208-585, 24208-590
- FDA application
- ANDA040064
- Affected lot / code info
- Lot #:199001, Expiry: 01/2016; Lot #: 222591, Expiry: 04/2016; Lot #: 224491, Expiry: 06/2016; Lot #: 229241, Expiry: 08/2016; Lot #: 232941, Expiry: 11/2016; Lot #: 239921, Expiry: 02/2017; Lot #: 241701, Expiry: 04/2017; Lot #: 246851, Expiry: 07/2017.
Why it was recalled
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Recalling firm
- Firm
- Bausch & Lomb, Inc.
- Manufacturer
- Bausch & Lomb Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8500 Hidden River Pkwy, N/A, Tampa, Florida 33637-1014
Distribution
- Quantity
- 119,393 Bottles
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2016-01-18
- FDA classified
- 2016-01-28
- Posted by FDA
- 2016-02-03
- Terminated
- 2020-01-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0646-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.