CLASS I Drug recall · Reported 26 Nov 2014 · FDA Enforcement Report
Trace Mineral-5 MDV, supplied in vials, Each ML contains recalled
Abrams Royal Pharmacy is recalling Trace Mineral-5 MDV, supplied in vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg, distributed nationwide in the US. The recall was initiated on 13 May 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0252-2015
- FDA event ID
- 68345
- Recalling firm
- Abrams Royal Pharmacy, Dallas, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 13 May 2013
- FDA classified
- 17 Nov 2014
- Reported
- 26 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Bacterial Contamination
- Drug class
- Injectable & IV Drugs
Timeline
| 13 May 2013 | Recall initiated by company | |
| 17 Nov 2014 | Classified by FDA | +553 days |
| 26 Nov 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Which lots are affected?
Lot number 04302013@21 (also written as 043013-21), exp 10/27/2013
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Abrams Royal Pharmacy
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine recalled | Abrams Royal Pharmacy | Sterility | TX |
| Drug | CLASS I | Calcium Chloride Preservative Free Sterile injection, 100 mg/ml vial recalled | Abrams Royal Pharmacy | Sterility | TX |