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Recall Observatory FDA recall evidence

Drug product

HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

D-0708-2021

October 05, 2020

Class I

Product summary

Firm
Med Shop Total Care Inc.
Event
Event 88291
Status
Terminated
Classification
Class I
Quantity
126 mL
Official record key
drug-enforcement:D-0708-2021

Official wording

Reason: Non-Sterility

Code information: Lot #: a)10012020@42, b) 10012020@43, c) 10012020@44, d) 10012020@46, e) 09302020@16, f) 09302020@44, BUD 10/29/2020

Distribution pattern: Texas and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility