Cyclopentolate Hydrochloride Solution/ Drops
FDA Recall NDC 24208-735
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cyclopentolate Hydrochloride (NDC 24208-735). 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
a) 905,956 Bottles, b) 191,375 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
Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.
Batch or Lot Expiration Information
Lot# a)
Lot# : 199691, Expiry: 02/2016
Lot# 221481, Expiry: 03/2016
Lot# : 223921, Expiry: 05/2016
Lot# : 226211, Expiry: 06/2016
Lot# : 228611, Expiry: 08/2016
Lot# : 230711, Expiry: 09/2016
Lot# : 232591, Expiry: 11/2016
Lot# : 234551, Expiry: 12/2016
Lot# : 238871, Expiry: 01/2017
Lot# : 239801, Expiry: 02/2017
Lot# : 240951, Expiry: 02/2017
Lot# : 242801, Expiry: 04/2017
Lot# : 246551, Expiry: 06/2017. b)
Lot# : 199011, Expiry: 01/2016
Lot# : 199692, Expiry: 02/2016
Lot# : 221482, Expiry: 03/2016
Lot# : 222601, Expiry: 04/2016
Lot# : 223922, Expiry: 05/2016
Lot# : 226212, Expiry: 06/2016
Lot# : 228612, Expiry: 08/2016
Lot# : 230712, Expiry: 09/2016
Lot# : 232592, Expiry: 11/2016
Lot# : 234552, Expiry: 12/2016
Lot# : 238872, Expiry: 01/2017
Lot# : 239802, Expiry: 02/2017
Lot# : 240952, Expiry: 02/2017
Lot# : 242802, Expiry: 04/2017
Lot# : 246552, Expiry: 06/2017.
Affected Packages Involved in this Recall
24208-735-01Product
24208-735-06Product
24208-735-05Product
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.
