FDA Drug recall D-0646-2016
Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only
- FDA Drug
- Class III
- terminated
- Published 2016-02-03
On 2016-02-03 the FDA classified a Class III recall of Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only by Bausch And Lomb, citing labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0646-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-01-18 |
| Published | 2016-02-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bausch And Lomb |
| Distribution | US |
Product
Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.
Reason
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Identifiers
| ndc | 24208-590-64 |
|---|---|
| ndc | 24208-585-59 |
| ndc | 24208-585-64 |
| code_info | Lot #:199001, Expiry: 01/2016; Lot #: 222591, Expiry: 04/2016; Lot #: 224491, Expiry: 06/2016; Lot #: 229241, Expiry: 0…Lot #:199001, Expiry: 01/2016; Lot #: 222591, Expiry: 04/2016; Lot #: 224491, Expiry: 06/2016; Lot #: 229241, Expiry: 08/2016; Lot #: 232941, Expiry: 11/2016; Lot #: 239921, Expiry: 02/2017; Lot #: 241701, Expiry: 04/2017; Lot #: 246851, Expiry: 07/2017. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0646-2016%22
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