The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0086-2017·Announced 2016-10-19

Pharmedium Recalls Phenylephrine Syringes Due to Stability Data Concerns

Pharmedium Services, LLC is recalling 498 syringes of Phenylephrine HCl because stability data does not support the expiry date, posing a risk of 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to a potential loss of potency, which is a theoretical risk of reduced efficacy rather than a direct physical injury or contamination hazard. No illnesses or injuries are reported in the source text.

Plain-English summary

Pharmedium Services, LLC is recalling 498 syringes of Phenylephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, Product code 2R3109. The recall is being conducted because stability data does not support the expiry date for the product, which may result in a potential loss of potency in drugs packaged and stored in syringes.

The affected product is identified by Lot Number 15112121M and has an expiration date between 07/15/15 and 10/12/15. The product was distributed nationwide. This is a prescription-only medication intended for intravenous use.

Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or a replacement. 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.

The recalled product

Product
PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3109.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable
Hazard
Affected units
498

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: 15112121M
  • 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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