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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80638

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 24, 2018
Product types
Drug
Classifications
Class II
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

3 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 3

10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.

D-1043-2018
Recall number
D-1043-2018
Initiated
July 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
PharMEDium Services, LLC
Quantity
230 Intravia Bags

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations: Product was released while a hood certification discrepancy was being investigated.

Code information

Lot 181760013D, 181730007D, Exp 08/09/2018, 09/02/2018

Distribution pattern

Product was distributed throughout the United States

drug · product 2 of 3

5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.

D-1044-2018
Recall number
D-1044-2018
Initiated
July 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
PharMEDium Services, LLC
Quantity
450 Syringes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations: Product was released while a hood certification discrepancy was being investigated.

Code information

Lot 181730039D, Exp 09/20/2018

Distribution pattern

Product was distributed throughout the United States

drug · product 3 of 3

10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.

D-1045-2018
Recall number
D-1045-2018
Initiated
July 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
PharMEDium Services, LLC
Quantity
575 Syringes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations: Product was released while a hood certification discrepancy was being investigated.

Code information

Lot 181780003D

Distribution pattern

Product was distributed throughout the United States