Prescription drug
Where is Cyclopentolate made?
4 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 2 factories in the United States.
United States 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn5 mg per 1 mL · NDC 17478-096 | AkornMakes it, tests it, packages it, labels it and sterilizes it | Location not on file | Not inspected on record |
| Alcon Laboratories, Inc.5 mg per 1 mL, 10 mg per 1 mL, 20 mg per 1 mL · NDC 0065-0396, 0065-0397, 0065-0395 | Alcon Research LLCMakes it | Fort Worth, TX, United States | No problems foundSep 2022 |
| Bausch & Lomb Incorporated10 mg per 1 mL · NDC 24208-735 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Sandoz Inc.10 mg per 1 mL · NDC 61314-396 | Alcon Research LLCMakes it | Fort Worth, TX, United States | No problems foundSep 2022 |
Repackaged by
These companies buy Cyclopentolate in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-3874,50090-3234 - Physicians Total Care, Inc.:
54868-4697 - Rebel Distributors Corp..:
21695-883,42254-013
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.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.