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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77988

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

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Event summary

Timeline bucket
August 15, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Amphastar Pharmaceuticals, Inc.

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

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00

D-1124-2017
Recall number
D-1124-2017
Initiated
August 15, 2017
Classification
Class II
Status
Terminated
Quantity
637,810 vials

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.

Code information

Lot # XI002A6, XI003A6, Exp 12/17; XI004G6, XI005G6, Exp 6/18; XI007H6, Exp 7/18; XI00816, XI00916, XI01016, XI01116, Exp 8/18; XI012J6, XI013J6, Exp 9/18; XI015K6, Exp 10/18; XI016L6, Exp 11/18; XL018A7, XI019A7, Exp 12/18; XI020B7, XI021B7, Exp 1/19; XI022C7, XI023C7, Exp 2/19; XI025D7, Exp 3/19.

Distribution pattern

Distributed throughout the United States

Field note

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