Exact FDA event identifier

Event 68345

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: May 13, 2013
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Abrams Royal Pharmacy

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0252-2015

Recall number: D-0252-2015
Initiated: May 13, 2013
Classification: Class I
Status: Terminated
Recalling firm: Abrams Royal Pharmacy
Quantity: 21 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Non-Sterility; contract laboratory identified Staphylococcus warneri in the product

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility; contract laboratory identified Staphylococcus warneri in the product

Code information

Lot number 04302013@21 (also written as 043013-21), exp 10/27/2013

Distribution pattern

Nationwide