Reported Feb 3, 2016 · Terminated
Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL…
Bausch & Lomb, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bausch & Lomb, Inc. · 8500 Hidden River Pkwy · Tampa, FL · 33637-1014
Is this the product you have?
- Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%
- Packaged in a) 2 mL Bottles (NDC24208-735-01)
- and b) 15 mL Bottles (NDC24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637
- Lot codes and dates
26 of 26 products
Products covered by this recall # Product as published 1 199691, Expiry: 02/2016 2 Lot # 221481, Expiry: 03/2016, Lot #: 223921, Expiry: 05/2016 3 Lot #: 226211, Expiry: 06/2016 4 Lot #: 228611, Expiry: 08/2016 5 Lot #: 230711, Expiry: 09/2016 6 Lot #: 232591, Expiry: 11/2016 7 Lot #: 234551, Expiry: 12/2016 8 Lot #: 238871, Expiry: 01/2017 9 Lot #: 239801, Expiry: 02/2017 10 Lot #: 240951, Expiry: 02/2017 11 Lot #: 242801, Expiry: 04/2017 12 Lot #: 246551, Expiry: 06/2017. b) Lot #: 199011, Expiry: 01/2016 13 Lot #: 199692, Expiry: 02/2016 14 Lot #: 221482, Expiry: 03/2016 15 Lot #: 222601, Expiry: 04/2016 16 Lot #: 223922, Expiry: 05/2016 17 Lot #: 226212, Expiry: 06/2016 18 Lot #: 228612, Expiry: 08/2016 19 Lot #: 230712, Expiry: 09/2016 20 Lot #: 232592, Expiry: 11/2016 - Amount recalled
- a) 905,956 Bottles, b) 191,375 Bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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