The Recall Desk
SevereFDA (Drugs)·D-1824-2015·Announced 2015-09-30

PharMEDium Recalls Morphine Sulfate IV Bags Due to Particulate Matter

PharMEDium Services is recalling 100 bags of Morphine Sulfate IV solution because the sodium chloride used 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 classified this as an FDA Class I recall, which mandates a severity score of at least 4 according to the rubric.

Plain-English summary

PharMEDium Services, LLC is recalling 100 bags of Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only. The product is identified by NDC# 61553-181-50. The recall is due to the presence of particulate matter, specifically human hair, in the Hospira 0.9% Sodium Chloride, USP injection used to manufacture the product.

The affected lots are 14308162M (Exp 02/02/15), 143130049M (Exp 02/08/15), 143220039M (Exp 02/16/15), 143490058M (Exp 03/16/15), and 143560029M (Exp 03/23/15). The products were distributed nationwide.

Healthcare providers and patients should discontinue use of the affected lots and contact PharMEDium Services, LLC for further instructions.

The recalled product

Product
Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-181-50
Manufacturer
Pharmedium Services, LLC
Category
Drug — IV Solution
Hazard
Affected units
100

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 #: 14308162M
  • Exp 02/02/15
  • 143130049M
  • Exp 02/08/15
  • 143220039M
  • Exp 02/16/15
  • 143490058M
  • Exp 03/16/15
  • 143560029M
  • Exp 03/23/15

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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