Recalls / Class II
Class IID-0018-2023
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
- Brand name
- Pyridostigmine Bromide
- Generic name
- Pyridostigmine Bromide
- Active ingredient
- Pyridostigmine Bromide
- Route
- Oral
- NDC
- 66689-406
- FDA application
- ANDA211694
- Affected lot / code info
- Lot#: 832400, Exp 08/2023
Why it was recalled
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Recalling firm
- Firm
- VistaPharm, Inc.
- Manufacturer
- VistaPharm, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 1980 cups
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-09-30
- FDA classified
- 2022-10-21
- Posted by FDA
- 2022-11-02
- Terminated
- 2024-04-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0018-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.