Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
Reported: September 18, 2013 Initiated: August 23, 2013 #D-1025-2013
Product Description
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
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.
Details
- Recalling Firm
- South Coast Specialty Compounding, Inc.
- Units Affected
- 297 vials
- Distribution
- CA, IN
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA. Recalled by South Coast Specialty Compounding, Inc.. Units affected: 297 vials.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on September 18, 2013. Severity: Moderate. Recall number: D-1025-2013.
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