Pharmakon Recalls Ketamine Syringes Due to Insufficient Stability Data
Pharmakon Pharmaceuticals is recalling 600 syringes of Ketamine 100 mg/mL because stability data does not support the expiration dates.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a stability data issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 600 syringes of Ketamine 100 mg/mL, injectable, prescription-only. The product is distributed nationwide.
The recall is being conducted because stability data does not support the expiration dates for the affected lots. The recall includes all lots with expiration dates up to 11/17/2015.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots with expiration dates up to 11/17/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Pharmakon Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
Same manufacturer · Pharmakon Pharmaceuticals
See all →- CriticalPharmakon Recalls Morphine Sulfate Syringes Due to High Potency
FDA (Drugs) · 2016-06-01
- ModeratePharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Concerns
FDA (Drugs) · 2016-02-03
- SeverePharmakon Recalls Hydromorphone Syringes Due to Stability Data Issues
FDA (Drugs) · 2016-02-03
Same hazard · stability data
See all →- ModerateOxytocin USP Powder Recalled Due to Insufficient Stability Data
FDA (Drugs) · 2018-03-21
- ModerateAmerican Pharmaceutical Ingredients Recalls Sermorelin Acetate Powder Due to Stability Data
FDA (Drugs) · 2018-03-21
- SevereApollo Care Recalls Vancomycin IV Bags Due to Stability Data Issues
FDA (Drugs) · 2018-03-14
- ModerateKalchem Recalls Vardenafil HCl Due to Missing Stability Data
FDA (Drugs) · 2018-03-14
- ModerateLevofloxacin Hemihydrate Recalled for Lack of Stability Data
FDA (Drugs) · 2018-02-28
Similar recalls
- SeverePharmakon Recalls Ketamine Syringes Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmedium Recalls Ketamine HCl Injection Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- SeverePharmakon Recalls Ketamine Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- ModeratePharmedium Recalls Ketamine HCl Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- ModeratePharmedium Recalls Fentanyl Citrate Injection Syringes Due to Stability Concerns
FDA (Drugs) · 2016-10-19
- SeverePharmedium Recalls Ketamine HCl Injection Due to Potential Loss of Potency
FDA (Drugs) · 2016-10-19