NDC 54868-4697
Cyclopentolate Hydrochloride 10 mg per 1 mL solution/ drops
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Bausch & Lomb Incorporated's NDC 24208-735.
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 |
Repackaging site
- Physicians Total Care, Inc., Tulsa, Oklahoma, United States · relabels it
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: 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 #: 23…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Cyclopentolate: every company that makes it
- Form
- solution/ drops
- Strength
- 10 mg per 1 mL
- Approval
- ANDA ANDA040075
- On the market since
- Jan 10, 2013
- Package NDCs
54868-4697-1- Official label
- DailyMed (National Library of Medicine), updated Feb 6, 2013
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