Pharmakon Recalls Ketamine Syringes Due to Insufficient Stability Data
Pharmakon Pharmaceuticals is recalling 250 syringes of Ketamine 50 mg/mL because stability data does not support the expiration dates.
What this means for you
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, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The specific issue is a stability data discrepancy rather than a confirmed contamination or acute injury risk.
Plain-English summary
Pharmakon Pharmaceuticals is recalling 250 syringes of Ketamine 50 mg/mL, a prescription-only injectable medication. The recall affects all lots with expiration dates up to 11/17/2015. The product was distributed nationwide.
The recall was initiated because stability data does not support the expiration dates for the affected product. This indicates that the medication may not remain stable or effective until the printed expiration date.
Consumers and healthcare providers should stop using the affected syringes and contact Pharmakon Pharmaceuticals for further instructions or a return.
The recalled product
- Product
- Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 250
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 Ketamine Syringes Due to Insufficient Stability Data
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Concerns
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
- ModerateKalchem Recalls Vardenafil HCl Due to Missing Stability Data
FDA (Drugs) · 2018-03-14
- SevereApollo Care Recalls Vancomycin IV Bags Due to Stability Data Issues
FDA (Drugs) · 2018-03-14
- ModerateNandrolone Decanoate USP Recalled for Lack of Stability Data
FDA (Drugs) · 2018-02-28