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Recall Observatory FDA recall evidence

Drug product

Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After Dilution Only, Park Compounding, Irvine, CA

D-1026-2013

August 23, 2013

Class II

Product summary

Firm
South Coast Specialty Compounding, Inc.
Event
Event 66083
Status
Terminated
Classification
Class II
Quantity
82 vials
Official record key
drug-enforcement:D-1026-2013

Official wording

Reason: Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.

Code information: Lot #05212013@20 and Lot#03212013@6, Exp 11/17/2013

Distribution pattern: CA, IN

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility