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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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…
- 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.
Related recalls
Same manufacturer · Abrams Royal Pharmacy
See all →- CriticalAbrams Royal Pharmacy Recalls Non-Sterile Lidocaine and Bupivacaine Syringes
FDA (Drugs) · 2014-11-26
- CriticalAbrams Royal Pharmacy Recalls Calcium Chloride Injection Due to Sterility Failures
FDA (Drugs) · 2014-11-26
Same hazard · non sterility
See all →- SevereChloraPrep One-Step Antiseptic Solution Recall Due to Sterility Concerns
FDA (Drugs) · 2026-07-01
- SevereChloraPrep One-Step Topical Antiseptic Recalled for Non-Sterility
FDA (Drugs) · 2026-07-01
- SevereLSL Healthcare Infant Central Line Dressing Change Kit Recalled
FDA (Devices) · 2026-04-29
- HighLSL Healthcare Central Line Dressing Change Kit Recalled for Non-Sterility
FDA (Devices) · 2026-04-29
- HighLSL Healthcare Wound Closure Tray Model 7554 Recalled for Non-Sterility
FDA (Devices) · 2026-04-29
Similar recalls
- CriticalAbrams Royal Pharmacy Recalls Calcium Chloride Injection Due to Sterility Failures
FDA (Drugs) · 2014-11-26
- CriticalAbrams Royal Pharmacy Recalls Non-Sterile Mineral IV Injection
FDA (Drugs) · 2014-09-03
- SevereUS Compounding Recalls Trace Elements-4 IV Vials Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SeverePromise Pharmacy Recalls Multi Trace Injection Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
- SevereRed Mountain Compounding Recalls Magnesium Sulfate Injection Due to Sterility Concerns
FDA (Drugs) · 2019-11-13
- SevereWells Pharmacy Recalls MIC/Chromium/B12 Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11