FDAClass IISeptember 18, 2013

Multitrace-5 Concentrate recall: Sterility Concern

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

Why was Multitrace-5 Concentrate recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After Dilution Only…
Recalling firm
South Coast Specialty Compounding, Inc.
Quantity
82 vials
Distribution
CA, IN
Recall date
September 18, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls