Drug 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
D-0018-2023
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 90943
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1980 cups
- Official record key
drug-enforcement:D-0018-2023
Official wording
Reason: cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Code information: Lot#: 832400, Exp 08/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations
-
Potency or specification failure
Out of specification