Recalls / Class II
Class IID-1156-2019
Product
Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 mL Syringe, 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
- 2 syringes
- 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-1156-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.