Manufacturer profile
Biogen MA Inc
Pharmaceutical company1 products tracked
1
products tracked
112,048
total reports
0
recalls on record
76.6%
serious overall
Products
showing 1 of 1
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 2010 | 112,048 | Anti-cyclic citrullinated peptide antibody positive | 0 |
Recall history · 2 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Dec 9, 2020 | II | Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing. | Biogen MA Inc. |
| Jun 23, 2020 | III | cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. | Biogen MA Inc. |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Biogen MA 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.