The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0025-2017·Announced 2016-10-19

Pharmedium Recalls Atropine Sulfate Injection Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 4,407 syringes of atropine sulfate injection nationwide because stability data does not support the expiration dates, 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 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential loss of potency in a critical medication.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 4,407 syringes of atropine sulfate injection, 0.4 mg per mL (1 mg per 2.5 mL), for intravenous use. The recall is being conducted because stability data does not support the expiration dates for the product, which creates a potential risk of loss of potency in the medication.

The affected product is identified by product code 2R3324 and includes specific lot numbers with expiration dates ranging from July 15, 2015, to October 12, 2015. The recall is classified as FDA 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.

The recalled product was distributed nationwide. Healthcare providers and patients should discontinue use of the affected syringes and contact Pharmedium Services, LLC for further instructions or to arrange for a return or replacement.

The recalled product

Product
atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injection
Hazard
Affected units
4,407

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 (10)

  • Lot Numbers: 15146085M
  • 15147088M
  • 15149011M
  • 15149109M
  • 15150093M
  • 151730001M
  • 151740139M
  • 151900018M
  • 151910014M
  • 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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