Corticosteroid
Where is Diflorasone made?
3 companies sell it under their own name. Their labels name 3 factories in the United States and Canada.
United States 2Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.0.5 mg per 1 g, 5 mg per 1 g · NDC 51672-1295, 51672-1296, 51672-5292 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Rising Pharma Holdings, Inc.0.5 mg per 1 g · NDC 64980-124 | Lyne Laboratories, Inc.Makes it | Brockton, MA, United States | Problems found, fixed voluntarilyMar 2026 |
| Teligent Pharma, Inc.0.5 mg per 1 g · NDC 52565-063 | Teligent Pharma, Inc.Makes it | Buena, New Jersey, United States | Serious problems, FDA actionAug 2021 |
Recalls
- Jun 24, 2024 · Class III · Rising Pharma Holding, Inc.
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit. - Mar 15, 2022 · Class II · Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - May 14, 2021 · Class II · Teligent Pharma, Inc.
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.