Pharmakon Pharmaceuticals, Inc.

Complete recall history across all FDA and CPSC categories, 88 total recalls

Pharmakon Pharmaceuticals, Inc. 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 (88)

FDA drug safety enforcement actions by Pharmakon Pharmaceuticals, Inc.. Showing most recent 50.

Date Product Reason Class
Apr 20, 2016 Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by P... Lack of Assurance of Sterility Class II
Apr 20, 2016 Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compo... Lack of Assurance of Sterility Class II
Apr 20, 2016 HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Mon... Lack of Assurance of Sterility Class II
Apr 20, 2016 Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, C... Lack of Assurance of Sterility Class II
Apr 20, 2016 Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKO... Lack of Assurance of Sterility Class II
Apr 20, 2016 Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Br... Lack of Assurance of Sterility Class II
Apr 20, 2016 Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Co... Lack of Assurance of Sterility Class II
Apr 20, 2016 Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 ... Lack of Assurance of Sterility Class II
Apr 20, 2016 Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, ... Lack of Assurance of Sterility Class II
Apr 20, 2016 Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only,... Lack of Assurance of Sterility Class II
Apr 20, 2016 Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceu... Lack of Assurance of Sterility Class II
Apr 20, 2016 Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx ... Lack of Assurance of Sterility Class II
Apr 20, 2016 Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia ... Lack of Assurance of Sterility Class II
Apr 20, 2016 Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 ... Lack of Assurance of Sterility Class II
Apr 20, 2016 HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx ... Lack of Assurance of Sterility Class II
Apr 20, 2016 Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded b... Lack of Assurance of Sterility Class II
Apr 20, 2016 Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHAR... Lack of Assurance of Sterility Class II
Apr 20, 2016 Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL ... Lack of Assurance of Sterility Class II
Apr 20, 2016 Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded... Lack of Assurance of Sterility Class II
Apr 20, 2016 Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV U... Lack of Assurance of Sterility Class II
Apr 20, 2016 Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL ... Lack of Assurance of Sterility Class II
Apr 20, 2016 Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx O... Lack of Assurance of Sterility Class II
Apr 20, 2016 Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, ... Lack of Assurance of Sterility Class II
Apr 20, 2016 Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx... Lack of Assurance of Sterility Class II
Apr 20, 2016 Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Mono... Lack of Assurance of Sterility Class II
Apr 20, 2016 Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Co... Lack of Assurance of Sterility Class II
Apr 20, 2016 Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey... Lack of Assurance of Sterility Class II
Apr 20, 2016 Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARM... Lack of Assurance of Sterility Class II
Apr 20, 2016 Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;,... Lack of Assurance of Sterility Class II
Apr 20, 2016 Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PA... Lack of Assurance of Sterility Class II
Apr 20, 2016 Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by... Lack of Assurance of Sterility Class II
Apr 20, 2016 Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syri... Lack of Assurance of Sterility Class II
Apr 20, 2016 HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, ... Lack of Assurance of Sterility Class II
Apr 20, 2016 Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx... Lack of Assurance of Sterility Class II
Apr 20, 2016 Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/m... Lack of Assurance of Sterility Class II
Apr 20, 2016 Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoj... Lack of Assurance of Sterility Class II
Apr 20, 2016 Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only... Lack of Assurance of Sterility Class II
Apr 20, 2016 Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Com... Lack of Assurance of Sterility Class II
Apr 20, 2016 Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Bra... Lack of Assurance of Sterility Class II
Apr 20, 2016 Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx On... Lack of Assurance of Sterility Class II
Apr 20, 2016 Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx On... Lack of Assurance of Sterility Class II
Apr 20, 2016 Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey),... Lack of Assurance of Sterility Class II
Apr 20, 2016 Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by ... Lack of Assurance of Sterility Class II
Apr 20, 2016 Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Onl... Lack of Assurance of Sterility Class II
Apr 20, 2016 Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by ... Lack of Assurance of Sterility Class II
Apr 20, 2016 Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe, Rx Only, Compound... Lack of Assurance of Sterility Class II
Apr 20, 2016 Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Casse... Lack of Assurance of Sterility Class II
Apr 20, 2016 Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARM... Lack of Assurance of Sterility Class II
Apr 20, 2016 Ketamine 100mg/mL 1mL fill 3 mL syringe, Rx Only, Compounded by PHARMAKON Pha... Lack of Assurance of Sterility Class II
Apr 20, 2016 Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compou... Lack of Assurance of Sterility Class II

View all 88 drug recalls →

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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