Tropicamide Solution/ Drops
FDA Recall NDC 24208-585
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Tropicamide (NDC 24208-585). A significant event, classified as Class III, was initiated on Jan 18, 2016 by Bausch & Lomb Incorporated. The reported reason for this action was: "Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Jan 18, 2016
Feb 03, 2016
119,393 Bottles
Recall Profile & Regulatory Data
Event ID
73032
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Bausch & Lomb, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide including Puerto Rico.
Termination Date
Jan 06, 2020
Product Description
Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.
Batch or Lot Expiration Information
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.
Affected Packages Involved in this Recall
24208-590-64Product
24208-585-59Product
24208-585-64Product
Class III Terminated
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Jan 18, 2016
Feb 03, 2016
a) 416,441 Bottles b) 674,177 Bottles
Recall Profile & Regulatory Data
Event ID
73032
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Bausch & Lomb, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide including Puerto Rico.
Termination Date
Jan 06, 2020
Product Description
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.
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
24208-590-64Product
24208-585-59Product
24208-585-64Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
