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Recall Observatory FDA recall evidence

Drug product

FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

D-0706-2021

October 05, 2020

Class I

Product summary

Firm
Med Shop Total Care Inc.
Event
Event 88291
Status
Terminated
Classification
Class I
Quantity
21 mL
Official record key
drug-enforcement:D-0706-2021

Official wording

Reason: Non-Sterility

Code information: Lot #: 09302020@67 BUD: 10/29/2020

Distribution pattern: Texas and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility