Recall events
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Event 95427
Event summary
Timeline bucket September 25, 2024
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Fresenius Kabi Compounding, 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
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
10 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 10
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
D-0014-2025
Recall number D-0014-2025
Initiated September 25, 2024
Classification Class II
Status Terminated
Quantity 1313 bags
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP violations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP violations
Code information Lot# C274-000039006, exp. date 19-Jan-25
Distribution pattern Product was distributed to 125 direct accounts nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15398]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 10
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
D-0015-2025
Recall number D-0015-2025
Initiated September 25, 2024
Classification Class II
Status Terminated
Quantity 1631 bags
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP violations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP violations
Code information Lot # C274-000037046, exp. date 13-Oct-24
Distribution pattern Product was distributed to 125 direct accounts nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15880]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 10
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
D-0016-2025
Recall number D-0016-2025
Initiated September 25, 2024
Classification Class II
Status Terminated
Quantity 2756 bags
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP violations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP violations
Code information Lot #C274-000037039, exp. date 9-Oct-24 C274-000037239, exp. date 21-Oct-24
Distribution pattern Product was distributed to 125 direct accounts nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[594]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 10
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
D-0017-2025
Recall number D-0017-2025
Initiated September 25, 2024
Classification Class II
Status Terminated
Quantity 1378 bags
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP violations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP violations
Code information Lot # C274-000038499, exp. date 21-Dec-24
Distribution pattern Product was distributed to 125 direct accounts nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15992]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 10
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
D-0018-2025
Recall number D-0018-2025
Initiated September 25, 2024
Classification Class II
Status Terminated
Quantity 1082 bags
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP violations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP violations
Code information Lot # C274-000038004, exp. date 27-Nov-24
Distribution pattern Product was distributed to 125 direct accounts nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15784]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 10
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
D-0019-2025
Recall number D-0019-2025
Initiated September 25, 2024
Classification Class II
Status Terminated
Quantity 2151 bags
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP violations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP violations
Code information Lot # C274-000038582, exp. date 29-Nov-24
Distribution pattern Product was distributed to 125 direct accounts nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15391]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 10
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
D-0020-2025
Recall number D-0020-2025
Initiated September 25, 2024
Classification Class II
Status Terminated
Quantity 733 bags
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP violations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP violations
Code information Lot # C274-000038404, exp. date 18-Nov-24
Distribution pattern Product was distributed to 125 direct accounts nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14877]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 10
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59
D-0021-2025
Recall number D-0021-2025
Initiated September 25, 2024
Classification Class II
Status Terminated
Quantity 4436 bags
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP violations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP violations
Code information Lot # C274-000038801, exp. date 9-Oct-24 C274-000039045, exp. date 24-Oct-24 C274-000039240, exp. date 31-Oct-24
Distribution pattern Product was distributed to 125 direct accounts nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15384]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 10
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
D-0022-2025
Recall number D-0022-2025
Initiated September 25, 2024
Classification Class II
Status Terminated
Quantity 753 bags
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP violations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP violations
Code information Lot # C274-000038958, exp. date 17-Oct-24 C274-000039206, exp. date 23-Oct-24
Distribution pattern Product was distributed to 125 direct accounts nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15988]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 10
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56
D-0023-2025
Recall number D-0023-2025
Initiated September 25, 2024
Classification Class II
Status Terminated
Quantity 1008 bags
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
cGMP violations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall cGMP violations
Code information Lot # C274-000037436, exp. date 30-Oct-24 C274-000038893, exp. date 7-Jan-25
Distribution pattern Product was distributed to 125 direct accounts nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15883]
FDA event record
· Exact recall-number query on openFDA
