The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0081-2017·Announced 2016-10-19

Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 25 syringes of morphine sulfate 2 mg/mL due to stability data that does not support the expiry date, posing a risk of potential loss of 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as loss of potency in a potent opioid) are categorized as Severe (Score 4), particularly when no specific hospitalization reports are provided but the risk is significant.

Plain-English summary

Pharmedium Services, LLC is recalling 25 syringes of morphine sulfate, 2 mg per mL, in 0.9% sodium chloride, 1 mL total volume, for IV use. The product is identified by product code 2T6455, lot number 15125033M, and expiration dates between 07/15/15 and 10/12/15. The recall was initiated because stability data does not support the expiry date, which may result in a potential loss of potency in the drug.

The recalled product was distributed nationwide. This is a prescription-only medication intended for intravenous use. 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.

Consumers and healthcare providers should stop using the affected syringes and contact their pharmacist or healthcare provider for further instructions. The recalling firm, Pharmedium Services, LLC, is responsible for managing the recall and addressing any questions regarding the product.

The recalled product

Product
morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Opioid Analgesic
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: 15125033M
  • 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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