Multi event Drug Recall Enforcement Report Class III voluntary initiated by Bausch & Lomb, Inc., originally initiated on 01-18-2016 for the 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. The product was recalled due to labeling: incorrect or missing package insert: package insert is missing updates compared with reference drug insert.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0645-2016 | 01-18-2016 | 02-03-2016 | Class III | a) 905,956 Bottles, b) 191,375 Bottles | 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. | Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. | Terminated |
| D-0646-2016 | 01-18-2016 | 02-03-2016 | Class III | 119,393 Bottles | Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64. | Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. | Terminated |
| D-0647-2016 | 01-18-2016 | 02-03-2016 | Class III | a) 416,441 Bottles b) 674,177 Bottles | Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. | Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. | Terminated |
Recalled Products
