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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug

Bausch & Lomb, Inc.: Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

Agency Publication Date: January 28, 2016
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Affected Products

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.

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.

Lot Numbers:
199691
221481
223921
226211
228611
230711
232591
234551
238871
239801
240951
242801
246551
199011
199692
221482
222601
223922
226212
228612
230712
232592
234552
238872
239802
240952
242802
246552
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.

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.

Lot Numbers:
199001
222591
224491
229241
232941
239921
241701
246851
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.

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.

Lot Numbers:
232601
233471
234901
238861
239781
243351
244931
198821
198901
199961
220111
222281
222291
224841
228281
228291
231531
232671
232681
238931
238941
240331
242341
242351
243391
246171
246341

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73032
Status: Resolved
Manufacturer: Bausch & Lomb, Inc.
Manufactured In: United States
Units Affected: 3 products (a) 905,956 Bottles, b) 191,375 Bottles; 119,393 Bottles; a) 416,441 Bottles b) 674,177 Bottles)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.