FDAFDA · Food and drugs·Recall number D-0645-2016
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, 33637.
Published February 3, 2016 · Recall initiated: January 18, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CYCLOPENTOLATE HYDROCHLORIDE
- Manufacturer
- Bausch & Lomb, Inc.
- Distributor
- U.S. Nationwide including Puerto Rico.
- 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.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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