Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

Plain-English summary

Pharmedium Services, LLC is recalling 592 syringes of morphine sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only. The product is identified by Product code 2R3181 and Lot Numbers 15113049M and 15113050M, with expiration dates between 07/15/15 and 10/12/15. The recall was initiated because stability data does not support the expiry date, which creates a potential for loss of potency in the drugs packaged and stored in syringes.

The affected product was distributed nationwide. This recall is classified as Class II by the FDA, indicating a situation where 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 to arrange for a return. Consumers should verify the lot numbers and expiration dates against the information provided in this notice to determine if their product is affected.

The recalled product

Product

morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3181.

Manufacturer

Pharmedium Services, LLC

Category

Drug — Injectable Opioid

Hazard

• loss-of-potency

Affected units

592

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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