FDA Drug recall D-0018-2023
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689…
- FDA Drug
- Class II
- terminated
- Published 2022-11-02
On 2022-11-02 the FDA classified a Class II recall of Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689… by Vistapharm, citing cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0018-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-09-30 |
| Published | 2022-11-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vistapharm |
| Distribution | US |
Product
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01
Reason
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Identifiers
| ndc | 66689-406-01 |
|---|---|
| ndc | 66689-406-10 |
| code_info | Lot#: 832400, Exp 08/2023 |
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-0018-2023%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.