Pharmedium Recalls Ketamine HCl Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 1,500 syringes of ketamine HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.
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 the hazard involves a potential loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Pharmedium Services, LLC is recalling 1,500 syringes of ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, Product code 2R3320. The recall is being conducted because stability data does not support the expiration dates for the product, which may result in a potential loss of potency in the drug.
The affected product is distributed nationwide. The specific lot numbers involved are 151120100M, 15112020M, 15112094M, and 15113012M, with expiration dates ranging between 07/15/15 and 10/12/15.
Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or a replacement.
The recalled product
- Product
- ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3320.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,500
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 (5)
- Lot Numbers: 151120100M
- 15112020M
- 15112094M
- 15113012M
- Exp between 07/15/15-10/12/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 69 recalled by Pharmedium Services, LLC 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.
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