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.

FDA recall notice · announced February 3, 2016 · Bausch & Lomb

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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.

Reason for recall

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

Notes

Distribution: U.S. Nationwide including Puerto Rico.
Lot/code information: 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.
Quantity: a) 905,956 Bottles, b) 191,375 Bottles
Status: Terminated
Products in this recall event:
- Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64. (D-0646-2016)
- 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. (D-0647-2016)
- 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, 33 (D-0645-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.