FDA Recall D-0252-2015
Abrams Royal Pharmacy · Dallas, TX
Class I — life-threatening Terminated 1243 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Recall record
- Recall number
D-0252-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Nationwide
- Recall initiated
- 2013-05-13
- Classified by FDA Center
- 2014-11-17
- FDA published
- 2014-11-26
- Terminated
- 2016-10-07
- Recalling firm
- Abrams Royal Pharmacy
- Firm location
- Dallas, TX