Local Anesthetic
Where is Proparacaine made?
8 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 5 factories in India and the United States.
India 3United States 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn5 mg per 1 mL · NDC 17478-263 | AkornMakes it, tests it, packages it, labels it and sterilizes it | Location not on file | Not inspected on record |
| AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record | |
| Alcon Laboratories, Inc.5 mg per 1 mL · NDC 0998-0016 | Alcon Research LLCMakes it | Fort Worth, TX, United States | No problems foundSep 2022 |
| Bausch & Lomb Incorporated5 mg per 1 mL · NDC 24208-730 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Lifestar Pharma LLC.5 mg per 1 mL · NDC 70756-193 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| MWI/VetOne5 mg per 1 mL · NDC 13985-611 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Micro Labs Limited5 mg per 1 mL · NDC 42571-497 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Sandoz Inc.5 mg per 1 mL · NDC 61314-016 | Alcon Research LLCMakes it | Fort Worth, TX, United States | No problems foundSep 2022 |
| Somerset Therapeutics, LLC5 mg per 1 mL · NDC 70069-601 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
Repackaged by
These companies buy Proparacaine 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:
50090-0259,50090-1931,50090-1923 - H.J. Harkins Co., Inc.:
52959-705 - NuCare Pharmaceuticals.Inc.:
68071-4368,68071-5139 - Rebel Distributors Corp..:
21695-530 - Remedyrepack Inc.:
70518-3408 - Sportpharm LLC:
85766-039,85766-056,85766-057 - Stat Rx USA:
16590-195
Recalls
- Sep 11, 2024 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
Temperature abuse: Products exposed to improper temperature above drug label specifications. - Oct 13, 2022 · Class II · Akorn, Inc. · 2 recall notices
CGMP Deviations: - Dec 26, 2019 · Class III · Akorn, Inc.
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.