D-0018-2023 Class II Terminated
FDA drug recall D-0018-2023 was initiated by VistaPharm, Inc. on September 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 April 30, 2024). Affected quantity: 1980 cups.
Recall Details
- Product Type
- Drugs
- Report Date
- November 2, 2022
- Initiation Date
- September 30, 2022
- Termination Date
- April 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