Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA

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 (…

Recall #: D-1027-2013
Affected scope: 117 vials
Initiated: August 23, 2013

Compiled from official public sources by the publisher. · Updated September 2026

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South Coast Specialty Compounding, Inc. recalled Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Comp… - a moderate-severity action.

Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Comp… was recalled by South Coast Specialty Compounding, Inc. in September 18, 2013. Reason: Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml…. Check the official notice for the remedy. Verify recall #D-1027-2013 with the FDA Drug before acting.

The recall

South Coast Specialty Compounding, Inc. issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml….

Moderate
severity level: Class II
classification: September 18, 2013
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1027-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA

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.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	D-1027-2013
Date reported	September 18, 2013
Date initiated	August 23, 2013
Recalling firm	South Coast Specialty Compounding, Inc.
Firm location	Irvine, CA
Affected scope	117 vials
Distribution	CA, IN

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-1027-2013) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA. Recalled by South Coast Specialty Compounding, Inc.. Units affected: 117 vials.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on September 18, 2013. Severity: Moderate. Recall number: D-1027-2013.

Where was the recalled product distributed? ▼

Distribution: CA, IN.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

SODIUM PHOSPHATE DIBASIC/WATER FOR INJECT… 2013-09-18 SODIUM PHOSPHATE MONOBASIC/WATER FOR INJE… 2013-09-18 TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJ… 2013-09-18 TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/… 2013-09-18

Similar Drugs & Medications · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ… 2013-09-18 TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and… 2013-09-18 TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP… 2013-09-18 TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOL… 2013-09-18

Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported September 18, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026