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Recall Observatory FDA recall evidence

Drug product

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL

D-0906-2018

June 04, 2018

Class I

Product summary

Firm
HOSPIRA INC, LAKE FOREST
Event
Event 80167
Status
Terminated
Classification
Class I
Quantity
164,860 syringes
Official record key
drug-enforcement:D-0906-2018

Official wording

Reason: Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.

Code information: 72680LL, Exp. 1DEC2018 (NDC 0409-1782-03); 76510LL, Exp. 1APR2019 (NDC 0409-1782-69)

Distribution pattern: Nationwide in the U.S., Puerto Rico, and Guam

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter