Skip to content
Recall Observatory FDA recall evidence

Drug product

BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800

D-0679-2020

December 20, 2019

Class II

Product summary

Firm
Assurance Infusion
Event
Event 84546
Status
Terminated
Classification
Class II
Quantity
28 vials
Official record key
drug-enforcement:D-0679-2020

Official wording

Reason: Lack of sterility assurance.

Code information: Lots: 11132019@15 Exp. 02/11/2020; 12112019@25 Exp. 02/13/2020; 11202019@9 Exp. 02/13/2020

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility