Pharmedium Recalls Ketamine HCl Syringes Due to Stability Data Concerns

Plain-English summary

Pharmedium Services, LLC is recalling 9,101 syringes of ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, Product code 2R3330. 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 drugs packaged and stored in syringes.

The affected product was distributed nationwide. The recall includes specific lot numbers with expiration dates ranging from 07/15/15 to 10/12/15. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or a return. Consumers should verify the lot numbers and expiration dates against the list provided by the manufacturer to determine if their product is affected.

The recalled product

Product

ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3330.

Manufacturer

Pharmedium Services, LLC

Category

Drug — Injectable

Hazard

• loss-of-potency

Affected units

9,101

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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