Bausch & Lomb, Inc. recalls Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL B

Recalled February 3, 2016 · FDA recall D-0645-2016 · Bausch & Lomb

Hazard

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

Units

a) 905,956 Bottles, b) 191,375 Bottles

Sold at

U.S. Nationwide including Puerto Rico.

Description

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

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.

Manufacturer(s)

Bausch & Lomb, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →