The Recall Desk
SevereFDA (Drugs)·D-1826-2015·Announced 2015-09-30

Pharmedium Recalls Phenylephrine Injection Due to Human Hair Particulate Matter

Pharmedium Services is recalling 84 bags of Phenylephrine HCl injection because the sodium chloride base contained human hair.

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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

Pharmedium Services, LLC is recalling 84 bags of Phenylephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP. The product is packaged in 250 ml bags and is available by prescription only. The recall involves specific lots with expiration dates in February 2015.

The recall was initiated because the firm manufactured the products using Hospira 0.9% Sodium Chloride, USP injection, which was subsequently recalled due to the presence of particulate matter, specifically human hair. The affected product was distributed nationwide.

Healthcare providers and patients should stop using the affected lots and return them to the distributor or manufacturer for credit. Consumers should check their medication for the specific lot numbers and expiration dates listed in the recall notice.

The recalled product

Product
PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-156-50
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injection
Hazard
Affected units
84

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 (6)

  • Lot #: 14310063S
  • Exp 02/04/15
  • 14316086S
  • Exp 02/10/15
  • 14322138S
  • Exp 02/16/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

Related recalls

Same manufacturer · Pharmedium Services, LLC

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Same hazard · particulate matter

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