Pyridostigmine Bromide Oral Solution recall: CGMP Deviations
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
Why was Pyridostigmine Bromide Oral Solution recalled?
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 832400, Exp 08/2023
- 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
- Recalling firm
- VistaPharm, Inc.
- Quantity
- 1980 cups
- Distribution
- USA Nationwide
- Recall date
- November 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)