Why it was recalled
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Product description
Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX
Lot numbers, UPCs & expiration codes
Lot number 04302013@21 (also written as 043013-21), exp 10/27/2013
Where it was sold
Nationwide
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-0252-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 13, 2013
- FDA report date
- Nov 26, 2014
- Quantity
- 21 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Abrams Royal Pharmacy
Original FDA data
Every field from FDA enforcement report D-0252-2015, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 68345
- Address
- 8220 Abrams Rd
- Code information
- Lot number 04302013@21 (also written as 043013-21), exp 10/27/2013
- Postal code
- 75231-1402
- Report date
- Nov 26, 2014
- Product type
- Drugs
- Recall number
- D-0252-2015
- Classification
- Class I
- Recalling firm
- Abrams Royal Pharmacy
- Product quantity
- 21 vials
- Termination date
- Oct 7, 2016
- Reason for recall
- Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX
- Distribution pattern
- Nationwide
- Recall initiation date
- May 13, 2013
- Initial firm notification
- Telephone
- Center classification date
- Nov 17, 2014