Recalls / Class III
Class IIID-0647-2016
Product
Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.
- Brand name
- Tropicamide
- Generic name
- Tropicamide
- Active ingredient
- Tropicamide
- Route
- Ophthalmic
- NDCs
- 24208-585, 24208-590
- FDA application
- ANDA040064
- Affected lot / code info
- a) Lot #: 232601, Expiry: 01/2016; Lot #: 233471, Expiry: 02/2016; Lot #: 234901, Expiry: 03/2016; Lot #: 238861, Expiry: 04/2016; Lot #: 239781, Expiry: 04/2016; Lot #: 243351, Expiry: 08/2016; Lot #: 244931, Expiry: 09/2016. b) Lot #: 198821, Expiry: 01/2016; Lot #: 198901, Expiry: 01/2016; Lot #: 199961, Expiry: 02/2016; Lot #: 220111, Expiry: 02/2016; Lot #: 222281, Expiry: 04/2016; Lot #: 222291, Expiry: 04/2016; Lot #: 224841, Expiry: 06/2016; Lot #: 228281, Expiry: 07/2016; Lot #: 228291, Expiry: 07/2016; Lot #: 231531, 10/2016; Lot #: 232671, Expiry: 11/2016; Lot #: 232681, Expiry: 11/2016; Lot #: 238931, 01/2017; Lot #: 238941, Expiry: 01/2017; Lot #: 240331, Expiry: 02/2017; Lot #: 242341, Expiry: 04/2017; Lot #: 242351, Expiry: 04/2017; Lot #: 243391, Expiry: 05/2017; Lot #: 246171, Expiry: 06/2017; Lot #: 246341, 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
- a) 416,441 Bottles b) 674,177 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-0647-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.