The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0053-2017·Announced 2016-10-19

Pharmedium Recalls Ketamine Syringes Due to Potential Loss of Potency

Pharmedium Services, LLC is recalling 25 syringes of ketamine HCl because stability data does not support the expiry date, 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, but the hazard is a potential loss of potency rather than a direct physical injury or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Pharmedium Services, LLC is recalling 25 syringes of ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, Product code 2R3234. The recall is due to stability data that does not support the expiry date, which may result in a potential loss of potency in the drug.

The affected product is identified by Lot Number 15112064M and has an expiration date between 07/15/15 and 10/12/15. The product was distributed nationwide. This is a prescription-only medication intended for intravenous use.

Consumers and healthcare providers should stop using the affected syringes and contact their pharmacist or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product
ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3234.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
25

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 (2)

  • Lot Number: 15112064M
  • 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.

See all 69 products in this recall →

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