Multi-event January 2016 FDA Recall Tropicamide by Bausch & Lomb, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Bausch & Lomb, Inc. on January 18, 2016 for the product Tropicamide. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0645-2016 TERMINATED D-0646-2016 TERMINATED D-0647-2016 TERMINATED

Recall Number: D-0645-2016

Reason for Recall
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Initiated
01-18-2016
Reported
02-03-2016
Quantity
a) 905,956 Bottles, b) 191,375 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73032
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bausch & Lomb, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2020
Product Description About Product Description
Full technical description of the product.
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

24208-735-01 Cyclopentolate Hydrochloride
24208-735-06 Cyclopentolate Hydrochloride
24208-735-05 Cyclopentolate Hydrochloride

Recall Number: D-0646-2016

Reason for Recall
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Initiated
01-18-2016
Reported
02-03-2016
Quantity
119,393 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73032
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bausch & Lomb, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2020
Product Description About Product Description
Full technical description of the 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.

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

24208-590-64 Tropicamide
24208-585-59 Tropicamide
24208-585-64 Tropicamide

Recall Number: D-0647-2016

Reason for Recall
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Initiated
01-18-2016
Reported
02-03-2016
Quantity
a) 416,441 Bottles b) 674,177 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73032
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bausch & Lomb, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2020
Product Description About Product Description
Full technical description of the 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.

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

24208-590-64 Tropicamide
24208-585-59 Tropicamide
24208-585-64 Tropicamide