Drug product
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
D-0252-2015
Product summary
- Event
- Event 68345
- Status
- Terminated
- Classification
- Class I
- Quantity
- 21 vials
- Official record key
drug-enforcement:D-0252-2015
Official wording
Reason: Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Code information: Lot number 04302013@21 (also written as 043013-21), exp 10/27/2013
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product