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Class II: temporary or reversible health riskTerminated

South Coast Specialty Compounding Methylcobalamin Injection 5 mg/mL Recall

Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple…

South Coast Specialty Compounding, Inc. · Irvine, CA

Risk level
Class II
Reported by FDA
Sep 18, 2013
Recall ID
D-1025-2013
Check your lot numberHow we source this data

Summary

South Coast Specialty Compounding recalled Methylcobalamin Injection 5 mg/mL starting Aug 23, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1025-2013 on Sep 18, 2013. Reason: 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. Status: Terminated.

Why it was 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.

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

CA, IN

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1025-2013
Classification
Class II
Status
Terminated
Recall initiated
Aug 23, 2013
FDA report date
Sep 18, 2013
Quantity
297 vials
Recall type
Voluntary: Firm initiated
Recalling firm
South Coast Specialty Compounding, Inc.

Original FDA data

Every field from FDA enforcement report D-1025-2013, exactly as published.

Show all FDA fields
City
Irvine
State
CA
Status
Terminated
Country
United States
Event ID
66083
Address
9257 Research Dr
Code information
Lot #06132013@1, Exp 12/10/2013
Postal code
92618-4286
Report date
Sep 18, 2013
Product type
Drugs
Recall number
D-1025-2013
Classification
Class II
Recalling firm
South Coast Specialty Compounding, Inc.
Product quantity
297 vials
Termination date
Oct 17, 2013
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
Distribution pattern
CA, IN
Recall initiation date
Aug 23, 2013
Initial firm notification
Press Release
Center classification date
Sep 12, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1025-2013, published Sep 18, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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