NDC 85766-278
Tropicamide 10 mg per 1 mL solution/ drops
On the label: Sportpharm LLC. It's repackaged: Sportpharm LLC rebottles it from Bausch & Lomb Incorporated's NDC 24208-585.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Bausch & Lomb Incorporated | Tampa, FL, United States | Makes it | Serious problems, FDA actionMar 20, 2026 · 17 inspections, 3 with FDA action |
Recalls
- Jan 18, 2016 · Class III · Bausch & Lomb, Inc.
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Lots: 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. - Jan 18, 2016 · Class III · Bausch & Lomb, Inc.
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Lots: a) Lot #: 232601, Expiry: 01/2016; Lot #: 233471, Expiry: 02/2016; Lot #: 234901, Expiry: 03/2016; Lot #: 238861, Expiry: 04/2016; Lot #: 239781, Expiry: 04/2016; Lot #: 243351, Expiry: 08/2016; Lot #: 244931, Expiry: 09/2016. b) Lot #: 198821, Expiry: 01/2016; Lot #: 198901, Expiry: 01/2016; Lot #…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tropicamide: every company that makes it
- Form
- solution/ drops, ophthalmic
- Strength
- 10 mg per 1 mL
- Approval
- ANDA ANDA040064
- On the market since
- Jul 27, 1994
- Package NDCs
85766-278-15- Official label
- DailyMed (National Library of Medicine), updated Sep 10, 2026
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