Recall events
/
Event 72177
Event summary
Timeline bucket August 19, 2015
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Pharmakon Pharmaceuticals
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
22 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 22
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0588-2016
Recall number D-0588-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 4123
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[6388]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 22
Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0589-2016
Recall number D-0589-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 1150
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Subpotent drug.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[9625]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 22
Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0590-2016
Recall number D-0590-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[8489]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 22
Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0591-2016
Recall number D-0591-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 5875
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[8495]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 22
Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0592-2016
Recall number D-0592-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 2750
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[9356]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 22
Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0593-2016
Recall number D-0593-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 210
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Subpotent drug.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[6843]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 22
Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0594-2016
Recall number D-0594-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 4100
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[6406]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 22
Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0595-2016
Recall number D-0595-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 665
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[8492]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 22
Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0596-2016
Recall number D-0596-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 7100
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[9358]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 22
Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0597-2016
Recall number D-0597-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 475
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[6411]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 22
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0598-2016
Recall number D-0598-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 8000
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[7184]
FDA event record
· Exact recall-number query on openFDA
drug · product 12 of 22
Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0599-2016
Recall number D-0599-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 1530
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[9631]
FDA event record
· Exact recall-number query on openFDA
drug · product 13 of 22
Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0600-2016
Recall number D-0600-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 600
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[8491]
FDA event record
· Exact recall-number query on openFDA
drug · product 14 of 22
Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0601-2016
Recall number D-0601-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 525
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[6859]
FDA event record
· Exact recall-number query on openFDA
drug · product 15 of 22
Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0602-2016
Recall number D-0602-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 250
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[6838]
FDA event record
· Exact recall-number query on openFDA
drug · product 16 of 22
Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0603-2016
Recall number D-0603-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 5000
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[6976]
FDA event record
· Exact recall-number query on openFDA
drug · product 17 of 22
Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0604-2016
Recall number D-0604-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 400
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[9627]
FDA event record
· Exact recall-number query on openFDA
drug · product 18 of 22
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0605-2016
Recall number D-0605-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity 378
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[6855]
FDA event record
· Exact recall-number query on openFDA
drug · product 19 of 22
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0606-2016
Recall number D-0606-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[6400]
FDA event record
· Exact recall-number query on openFDA
drug · product 20 of 22
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0607-2016
Recall number D-0607-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[7197]
FDA event record
· Exact recall-number query on openFDA
drug · product 21 of 22
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0608-2016
Recall number D-0608-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[6973]
FDA event record
· Exact recall-number query on openFDA
drug · product 22 of 22
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
D-0609-2016
Recall number D-0609-2016
Initiated August 19, 2015
Classification Class II
Status Terminated
Quantity N/A
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Stability data does not support expiry
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Stability data does not support expiry.
Code information All lots with expiration dates up to 11/17/2015
Distribution pattern 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[9350]
FDA event record
· Exact recall-number query on openFDA
