Recalls / Class II
Class IID-1190-2019
Product
Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Affected lot / code info
- All Lots
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Attn: Cleve Anderson, 310 Bluff City Hwy, Bristol, Tennessee 37620-4602
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-04-02
- FDA classified
- 2019-04-18
- Posted by FDA
- 2019-04-24
- Terminated
- 2021-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1190-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.