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.
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, 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
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