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
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 numbers, UPCs & expiration codes
Lot #05212013@20 and Lot#03212013@6, Exp 11/17/2013
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-1026-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2013
- FDA report date
- Sep 18, 2013
- Quantity
- 82 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- South Coast Specialty Compounding, Inc.
Original FDA data
Every field from FDA enforcement report D-1026-2013, 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 #05212013@20 and Lot#03212013@6, Exp 11/17/2013
- Postal code
- 92618-4286
- Report date
- Sep 18, 2013
- Product type
- Drugs
- Recall number
- D-1026-2013
- Classification
- Class II
- Recalling firm
- South Coast Specialty Compounding, Inc.
- Product quantity
- 82 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
- 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
- Distribution pattern
- CA, IN
- Recall initiation date
- Aug 23, 2013
- Initial firm notification
- Press Release
- Center classification date
- Sep 12, 2013