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.
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, 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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