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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83207

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

Open FDA event record

Event summary

Timeline bucket
June 07, 2019
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
PharMEDium Services, LLC

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

Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78

D-1488-2019
Recall number
D-1488-2019
Initiated
June 07, 2019
Classification
Class I
Status
Terminated
Recalling firm
PharMEDium Services, LLC
Quantity
28,140 syringes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite

Code information

Lot #: 190670030D,190670031D, 190670032D, 190670033D, Exp. 6/9/2019; 190710015D, 190710016D, 190710017D, 190710018D, 190710019D, Exp. 6/11/2019; 190730028D, 190730029D, 190730030D, Exp. 6/13/2019; 190740018D, Exp.6/16/2019; 190770028D, 190770029D, Exp. 6/17/2019; 190780027D, 190780028D, 190780029D, Exp. 6/18/2019; 190790030D, Exp. 6/19/2019; 190800012D, 190800013D, 190800014D, 190800015D, 190800016D, Exp.6/20/2019; 190810033D, 190810034D, 190810035D,190810036D, Exp.6/23/2019; 190840002D, Exp. 6/24/2019; 190870008D, Exp. 6/27/2019; 190910015D, Exp. 7/1/2019; 190980033D, Exp. 7/8/2019; 190990017D, 190990030D, Exp. 7/9/2019; 191000035D, Exp. 7/10/2019; 191010008D,191010009D, 191010010D, Exp. 7/11/2019; 191050002D, Exp.7/15/2019; 191120002D, Exp.7/22/2019; 191160001D, Exp. 7/28/2019; 191210020D, 191210021D, 191210022D, Exp.7/31/2019; 191220017D, Exp.8/1/2019.

Distribution pattern

Nationwide within the United States

Field note

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