The Recall Desk
SevereFDA (Drugs)·D-0075-2017·Announced 2016-10-19

Pharmedium Recalls Midazolam Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 26,079 syringes of midazolam HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

What this means for you

Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the agency's classification is explicitly provided and no lower-severity criteria (like Class III) apply.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 26,079 syringes of midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use. The product is identified by Product code 2R3356 and was distributed nationwide. The recall involves specific lot numbers with expiration dates ranging from July 15, 2015, to October 12, 2015.

The recall is being conducted because stability data does not support the expiration dates for the drugs packaged and stored in syringes. This condition creates a potential for loss of potency in the medication. 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.

Healthcare providers and patients who have this product should stop using it and contact Pharmedium Services, LLC for further instructions or a return. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
26,079

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 (20)

  • Lot Numbers: 151170045M
  • 151170084M
  • 151170093M
  • 15117084M
  • 151180080M
  • 15118092M
  • 15118094M
  • 15119054M
  • 15120072M
  • 15121093M
  • 151240093M
  • 151240094M
  • 151240099M
  • 15124074M
  • 151250094M
  • 15126044M
  • 15126079M
  • 15126080M
  • 15127097M
  • 15127098M

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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Same hazard · loss of potency

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