Recalls / Class III
Class IIID-0645-2016
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.
- Brand name
- Cyclopentolate Hydrochloride
- Generic name
- Cyclopentolate Hydrochloride
- Active ingredient
- Cyclopentolate Hydrochloride
- Route
- Ophthalmic
- NDC
- 24208-735
- FDA application
- ANDA040075
- Affected 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.
Why it was recalled
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Recalling firm
- Firm
- Bausch & Lomb, Inc.
- Manufacturer
- Bausch & Lomb Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8500 Hidden River Pkwy, N/A, Tampa, Florida 33637-1014
Distribution
- Quantity
- a) 905,956 Bottles, b) 191,375 Bottles
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2016-01-18
- FDA classified
- 2016-01-28
- Posted by FDA
- 2016-02-03
- Terminated
- 2020-01-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0645-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.