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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84000

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

Open FDA event record

Event summary

Timeline bucket
October 09, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

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

PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25

D-0147-2020
Recall number
D-0147-2020
Initiated
October 09, 2019
Classification
Class II
Status
Terminated
Quantity
1855 bags

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP Deviations: potential glass contamination

Code information

Lots: FB9001 A Exp. 10/31/2019, FB9001B Exp. 10/31/2019; FB9013A Exp. 12/08/2019; FB9015A Exp. 12/14/2019

Distribution pattern

Nationwide.

drug · product 2 of 3

PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25

D-0148-2020
Recall number
D-0148-2020
Initiated
October 09, 2019
Classification
Class II
Status
Terminated
Quantity
1370 bags

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP Deviations: potential glass contamination

Code information

Lots: FB9014A Exp. 12/09/2019; FB9017A Exp. 12/16/2019

Distribution pattern

Nationwide.

drug · product 3 of 3

PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20

D-0149-2020
Recall number
D-0149-2020
Initiated
October 09, 2019
Classification
Class II
Status
Terminated
Quantity
615 bags

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP Deviations: potential glass contamination

Code information

Lot: FR9002A Exp. 12/12/2019

Distribution pattern

Nationwide.