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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68283

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

Open FDA event record

Event summary

Timeline bucket
May 31, 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

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

Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.

D-0250-2015
Recall number
D-0250-2015
Initiated
May 31, 2013
Classification
Class I
Status
Terminated
Recalling firm
Abrams Royal Pharmacy
Quantity
1,100 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility: The firm's contract testing laboratory found sterility failures.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: The firm's contract testing laboratory found sterility failures.

Code information

Lot #: 05152013@4 (also written as 051513-4), Exp 11/11/13

Distribution pattern

Two hospitals in Dallas, TX