Pharmakon Pharmaceuticals

Complete recall history across all FDA and CPSC categories — 28 total recalls

Pharmakon Pharmaceuticals appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (28)

FDA drug safety enforcement actions by Pharmakon Pharmaceuticals

Date Product Reason Class
Feb 11, 2016 Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, t... Super-Potent Drug: Out of specification for potency results (high) were obtai... Class I
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 m... Stability data does not support expiry. Class II
Aug 19, 2015 Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in... Stability data does not support expiry. Class II
Aug 19, 2015 Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5... Stability data does not support expiry. Class II
Aug 19, 2015 Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Tot... Stability data does not support expiry. Class II
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in ... Stability data does not support expiry. Class II
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 ... Stability data does not support expiry. Class II
Aug 19, 2015 Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 1... Stability data does not support expiry. Class II
Aug 19, 2015 Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosag... Stability data does not support expiry. Class II
Aug 19, 2015 Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in... Stability data does not support expiry. Class II
Aug 19, 2015 Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syri... Subpotent drug. Class II
Aug 19, 2015 Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/... Stability data does not support expiry. Class II
Aug 19, 2015 Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syrin... Stability data does not support expiry. Class II
Aug 19, 2015 Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharma... Stability data does not support expiry. Class II
Aug 19, 2015 Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syring... Subpotent drug. Class II
Aug 19, 2015 Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, ... Stability data does not support expiry. Class II
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 m... Stability data does not support expiry. Class II
Aug 19, 2015 Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syring... Stability data does not support expiry. Class II
Aug 19, 2015 Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, ... Stability data does not support expiry. Class II
Aug 19, 2015 Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in s... Stability data does not support expiry. Class II
Aug 19, 2015 Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syrin... Stability data does not support expiry. Class II
Aug 19, 2015 Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx... Stability data does not support expiry. Class II
Aug 19, 2015 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL i... Stability data does not support expiry. Class II
Apr 21, 2014 Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I
Apr 21, 2014 Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx ... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I
Apr 21, 2014 Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Ph... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I
Apr 21, 2014 Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharma... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class II
Mar 26, 2014 Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per... Superpotent Drug: Product contains twice the stated amount of midazolam. Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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