CLASS II Drug recall · Reported 18 Sep 2013 · FDA Enforcement Report
Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) recalled
South Coast Specialty Compounding is recalling Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile Multiple, distributed in California, Indiana. The recall was initiated on 23 Aug 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1026-2013
- FDA event ID
- 66083
- Recalling firm
- South Coast Specialty Compounding, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Aug 2013
- FDA classified
- 12 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Aug 2013 | Recall initiated by company | |
| 12 Sep 2013 | Classified by FDA | +20 days |
| 18 Sep 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
CA, IN
Questions about this recall
Is Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile Multiple recalled?
Yes. South Coast Specialty Compounding recalled Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile Multiple on 23 Aug 2013. The recall is Class II and its status is Terminated. Recall number D-1026-2013.
Why was it 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.
Which lots are affected?
Lot #05212013@20 and Lot#03212013@6, Exp 11/17/2013
Where was it sold?
CA, IN
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from South Coast Specialty Compounding
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|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol cream recalled by South Coast Specialty | South Coast Specialty Compounding | Other | Nationwide |
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