Abrams Royal Pharmacy Recalls Trace Mineral-5 MDV Due to Non-Sterility
Abrams Royal Pharmacy is recalling Trace Mineral-5 MDV vials because a contract laboratory identified Staphylococcus warneri in the product, indicating non-sterility.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Abrams Royal Pharmacy is recalling 21 vials of Trace Mineral-5 MDV, a compounded medication supplied in 10 mL vials. The product contains zinc, copper, manganese, chromium, selenium, and benzyl alcohol in water for injection. The recall is due to non-sterility, as a contract laboratory identified Staphylococcus warneri in the product.
The affected product is identified by Lot number 04302013@21 (also written as 043013-21) with an expiration date of 10/27/2013. The recall is classified as Class I by the U.S. Food and Drug Administration. The distribution pattern is listed as nationwide.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions. The source text does not specify the number of units distributed or report any illnesses or injuries associated with this recall.
The recalled product
- 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
- Manufacturer
- Abrams Royal Pharmacy
- Category
- Drug — Compounded Medication
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number 04302013@21 (also written as 043013-21)
- exp 10/27/2013
Distribution
Distributed nationwide across the United States.
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