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Recall Observatory FDA recall evidence

Drug product

HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

D-0711-2021

October 05, 2020

Class I

Product summary

Firm
Med Shop Total Care Inc.
Event
Event 88291
Status
Terminated
Classification
Class I
Quantity
84 mL
Official record key
drug-enforcement:D-0711-2021

Official wording

Reason: Non-Sterility

Code information: Lot #: a) 09282020@66, BUD 10/27/2020, 09302020@42, BUD 10/29/2020, b) 09282020@79, c) 09292020@32, BUD 10/27/2020 09282020@66 09302020@42 09282020@79 09292020@32 10/27/2020 10/29/2020 10/27/2020 10/27/2020

Distribution pattern: Texas and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility