FDA Drug recall D-0008-2022
Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. B…
- FDA Drug
- Class I
- terminated
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class I recall of Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. B… by Jacobus Pharmaceutical, citing microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0008-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-09-09 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jacobus Pharmaceutical |
| Distribution | n/a |
Product
Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.
Reason
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Identifiers
| code_info | Lot #: 18038, 18039, Exp 03/2023; 18079, Exp 05/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0008-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.