Orphenadrine Citrate recalls
Orphenadrine Citrate products have been recalled 2 times, most recently on 13 Apr 2022. The recalling company is usually Sandoz. The most common reason is nitrosamine impurity.
Total recalls2since 2014
Last 12 months0reported
Class I00% of total
Ongoing0latest 13 Apr 2022
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 1 50%Class III 1 50%
Why orphenadrine citrate is recalled
Companies
By year
All orphenadrine citrate recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Orphenadrine Citrate Extended-Release Tablets, USP 100 mg recalledOrphenadrine Citrate | Sandoz | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Orphenadrine Citrate Extended Release Tablets, 100 mg a) recalledOrphenadrine Citrate | Sandoz | Potency & Assay | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.