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Recall Observatory FDA recall evidence

Drug product

Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX

D-0251-2015

April 19, 2013

Class I

Product summary

Firm
Abrams Royal Pharmacy
Event
Event 68342
Status
Terminated
Classification
Class I
Quantity
50 syringes
Official record key
drug-enforcement:D-0251-2015

Official wording

Reason: Non-Sterility

Code information: Lot# 041013-13 (also been written as "041013@13") Exp: 06/09/2013

Distribution pattern: Texas

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility