Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Trace Mineral-5 MDV
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Drug: Alcohol
- Recalling firm
- Abrams Royal Pharmacy
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0252-2015 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Alcohol recalls
See all
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Other recalls by Abrams Royal Pharmacy
All 2013 recalls
Class I · High risk
Calcium Chloride Preservative Free Sterile injection
Non-Sterility: The firm's contract testing laboratory found sterility failures.
Class I · High risk
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