Manufacturer profile
CELLTRION USA, Inc.
Pharmaceutical company2 products tracked
2
products tracked
242,389
total reports
2
recalls on record
74.2%
serious overall
Products
showing 2 of 2
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 2010 | 198,114 | Osteonecrosis of jaw | 2 | |
| 2023 | 44,275 | Anti-cyclic citrullinated peptide antibody positive | 0 |
Recall history · 2 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Apr 21, 2025 | II | CGMP Deviations; potential temperature excursions due to transit delays | Mckesson Medical-Surgical Inc. Corporate Office |
| Sep 17, 2013 | II | Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination. | Amgen, Inc. |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from CELLTRION USA, Inc. are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.