D-0018-2023 Class II Terminated
FDA drug recall D-0018-2023 was initiated by VistaPharm, Inc. on Sep 30, 2022 and is designated Class II. Reason for recall: cGMP Deviations: Out of specification for assay of one of the preservative ingredients. The recall status is terminated (terminated Apr 30, 2024). Affected quantity: 1980 cups.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 2, 2022
- Initiation Date
- Sep 30, 2022
- Termination Date
- Apr 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1980 cups
Product Description
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 for Recall
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Distribution Pattern
USA Nationwide
Code Information
Lot#: 832400, Exp 08/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0018-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026