Quinolone Antimicrobial
Where is Ofloxacin made?
21 companies sell it under their own name and 19 repackagers rebottle it. Their labels name 8 factories in India, Switzerland and the United States.
India 6Switzerland 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn3 mg per 1 mL · NDC 17478-713 | 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 | |
| Ophtapharm AGMakes it, tests it, packages it and labels it | Hettlingen, Switzerland | Problems found, fixed voluntarilyFeb 2020 | |
| MWI/VetOne3 mg per 1 mL · NDC 13985-602 | 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 | |
| Ophtapharm AGMakes it, tests it, packages it and labels it | Hettlingen, Switzerland | Problems found, fixed voluntarilyFeb 2020 | |
| Armas Pharmaceuticals Inc.3 mg per 1 mL · NDC 72485-613 | Ophtapharm AGMakes it, tests it, packages it and labels it | Hettlingen, Switzerland | Problems found, fixed voluntarilyFeb 2020 |
| Bausch & Lomb Incorporated3 mg per 1 mL · NDC 24208-410, 24208-434 | Bausch & Lomb IncorporatedMakes it, packages it and labels it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Cadila Pharmaceuticals Limited200 mg, 300 mg, 400 mg · NDC 71209-097, 71209-098, 71209-099 | Cadila Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundSep 2025 |
| Caplin Steriles Limited3 mg per 1 mL · NDC 65145-143, 65145-144, 65145-141 +1 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| FDC Limited3 mg per 1 mL · NDC 55545-1003 | FDC LimitedMakes it and tests it | Chhatrapati Sambhajinagar, India | No problems foundFeb 2023 |
| Leading Pharma, LLC3 mg per 1 mL · NDC 69315-320, 69315-327 | Caplin Steriles LimitedMakes it | Gummidipoondi, India | No problems foundAug 2024 |
| Lifestar Pharma LLC.3 mg per 1 mL · NDC 70756-607, 70756-650, 70756-609 +1 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Major Pharmaceuticals3 mg per 1 mL · NDC 0904-7434 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Micro Labs Limited3 mg per 1 mL · NDC 42571-461 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Modavar Pharmaceuticals LLC200 mg, 300 mg, 400 mg · NDC 72241-072, 72241-073, 72241-074 | Cadila Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundSep 2025 |
| Northstar Rx LLC.3 mg per 1 mL · NDC 72603-192, 72603-186 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Rising Pharma Holdings, Inc.3 mg per 1 mL · NDC 64980-432, 64980-515 | FDC LimitedMakes it and tests it | Chhatrapati Sambhajinagar, India | No problems foundFeb 2023 |
| Somerset Therapeutics, LLC3 mg per 1 mL · NDC 70069-411, 70069-686, 70069-687 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Allergan, Inc. Ocuflox3 mg per 1 mL · NDC 11980-779 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Altaire Pharmaceuticals Inc.3 mg per 1 mL · NDC 59390-140 | The label doesn't name the factory. Plants this company names for other drugs | ||
| American Regent, Inc.3 mg per 1 mL · NDC 0517-0760, 0517-0761 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amneal Pharmaceuticals3 mg per 1 mL · NDC 69238-1616, 69238-1615 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.3 mg per 1 mL · NDC 60505-0363, 60505-0560 | The label doesn't name the factory. Plants this company names for other drugs | ||
| SOLA Pharmaceuticals, LLC3 mg per 1 mL · NDC 70512-793 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ofloxacin 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:
50090-5210,50090-3836,50090-1744,50090-6794+8 - Aidarex Pharmaceuticals LLC:
33261-737 - Asclemed USA, Inc.:
76420-748,76420-749 - Bryant Ranch Prepack:
63629-8716,72162-1709,71335-2822 - Direct Rx:
61919-175,61919-931,72189-108,72189-472+1 - H.J. Harkins Co., Inc.:
52959-763 - Keltman Pharmaceuticals Inc.:
68387-106 - NuCare Pharmaceuticals.Inc.:
68071-2894,68071-2834,68071-2910,68071-2544+10 - Physicians Total Care, Inc.:
54868-6112,54868-6035 - Preferred Pharmaceuticals, Inc..:
68788-8761,68788-4086,68788-7693,68788-8449 - Proficient Rx LP:
63187-734,63187-268,63187-472,63187-662+4 - RPK Pharmaceuticals, Inc.:
53002-5604,53002-1604,53002-2604,53002-6604+1 - Rebel Distributors Corp..:
21695-439,21695-881,42254-257 - RedPharm Drug. Inc.:
67296-0344,67296-1223,67296-1819,67296-1866+5 - Remedyrepack Inc.:
70518-3710,70518-3573,70518-3984,70518-4147+2 - Sportpharm LLC:
85766-226,85766-227 - St. Mary's Medical Park Pharmacy:
60760-970,60760-917 - Stat Rx USA:
16590-175,16590-931 - Unit Dose Services:
50436-6112,50436-0713
Recalls
- Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations: - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Jul 2, 2019 · Class II · Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.