Bausch & Lomb, Inc.: 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 Incorp

Is my product affected?

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.

• Brand CYCLOPENTOLATE HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

Bausch & Lomb is recalling Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, a prescription eye medication distributed nationwide including Puerto Rico. The recall affects two package sizes: 2 mL bottles (905,956 bottles) and 15 mL bottles (191,375 bottles). The product is being recalled because the package insert is missing updates that are included in the reference drug insert.

The affected lots span from January 2016 through June 2017, with specific lot numbers and expiration dates listed for each package size. According to the source document, no remedy is specified for consumers who have this medication.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. Distribution: U.S. Nationwide including Puerto Rico. Quantity: a) 905,956 Bottles, b) 191,375 Bottles Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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