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Recall Observatory FDA recall evidence

Drug product

Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

D-1191-2019

April 02, 2019

Class II

Product summary

Firm
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
Event
Event 82554
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1191-2019

Official wording

Reason: Lack of sterility assurance.

Code information: All Lots

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility