The Recall Desk
SevereFDA (Drugs)·D-0906-2018·Announced 2018-06-13

Hospira Recalls Naloxone Hydrochloride Injection Due to Particulate Matter

Hospira is recalling Naloxone Hydrochloride Injection cartridges due to the presence of particulate matter on the syringe plunger.

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

Hospira Inc. is recalling Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringes. The recall affects 164,860 syringes distributed nationwide in the U.S., Puerto Rico, and Guam.

The recall was initiated due to the presence of particulate matter and the potential for particulate matter on the syringe plunger. The affected products are identified by lot numbers 72680LL (Exp. 1DEC2018) and 76510LL (Exp. 1APR2019).

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE)
Brand
NALOXONE HYDROCHLORIDE
Manufacturer
HOSPIRA INC, LAKE FOREST
Category
Drug — Injection
Hazard
Affected units
164,860

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 (4)

  • 72680LL
  • Exp. 1DEC2018 (NDC 0409-1782-03)
  • 76510LL
  • Exp. 1APR2019 (NDC 0409-1782-69)

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same manufacturer · HOSPIRA INC, LAKE FOREST

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Same hazard · particulate matter

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