CLASS II Drug recall · Reported 18 Sep 2013 · FDA Enforcement Report
Testosterone Cypionate (Sesame Oil) 200mg/mL recalled
South Coast Specialty Compounding is recalling Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in amber vials, Park, 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-1027-2013
- 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 voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due 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
Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA
Where it was distributed
CA, IN
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance.
Which lots are affected?
Lot #05072013@1, Exp 11/3/2013
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 66083This product is part of a recall event; the main page for the event is Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) recalled | South Coast Specialty Compounding | Sterility | CA, IN | |
| CLASS II | Methylcobalamin Injection 5 mg/mL recalled by South Coast Specialty | South Coast Specialty Compounding | Sterility | CA, IN |
More recalls from South Coast Specialty Compounding
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol cream recalled by South Coast Specialty | South Coast Specialty Compounding | Other | Nationwide |
| Drug | CLASS II | Estradiol, Estriol, Progesterone capsules recalled | South Coast Specialty Compounding | Other | Nationwide |
| Drug | CLASS II | Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone recalled | South Coast Specialty Compounding | Other | Nationwide |
| Drug | CLASS II | Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops recalled | South Coast Specialty Compounding | Other | Nationwide |
| Drug | CLASS II | Estriol,Estradiol cream recalled by South Coast Specialty | South Coast Specialty Compounding | Other | Nationwide |
Other Testosterone Cypionate (sesame Oil recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate Injection (Sesame Oil), 200mg/mL vial recalled | Downing Labs | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate (Sesame Oil/Cmpd), 200mg/mL recalled | Oregon Compounding Centers | Sterility | OR, WA |
| Drug | CLASS II | Testosterone Cypionate (Sesame Oil) 200mg/mL Injection Vial recalled | University Compounding Pharmacy | Sterility | Nationwide |