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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

South Coast Specialty Compounding, Inc.: 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.; 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.

Agency Publication Date: September 12, 2013
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Affected Products

Product: Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA

Lot #06132013@1, Exp 12/10/2013

Lot Numbers:
06132013
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

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

Lot Numbers:
05212013
03212013
Product: Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA

Lot #05072013@1, Exp 11/3/2013

Lot Numbers:
05072013

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 66083
Status: Resolved
Manufacturer: South Coast Specialty Compounding, Inc.
Manufactured In: United States
Units Affected: 3 products (297 vials; 82 vials; 117 vials)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.