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Recall Observatory FDA recall evidence

Drug product

HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

D-0709-2021

October 05, 2020

Class I

Product summary

Firm
Med Shop Total Care Inc.
Event
Event 88291
Status
Terminated
Classification
Class I
Quantity
42 mL
Official record key
drug-enforcement:D-0709-2021

Official wording

Reason: Non-Sterility

Code information: Lot #: a) 09302020@30, BUD 10/23/2020, b) 10022020@14, BUD 10/30/2020

Distribution pattern: Texas and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility