FDA Recall D-0906-2018
HOSPIRA INC, LAKE FOREST · LAKE FOREST, IL
Class I — life-threatening Terminated 662 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Recall record
- Recall number
D-0906-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the U.S., Puerto Rico, and Guam
- Recall initiated
- 2018-06-04
- Classified by FDA Center
- 2018-07-02
- FDA published
- 2018-06-13
- Terminated
- 2020-03-27
- Recalling firm
- HOSPIRA INC, LAKE FOREST
- Firm location
- LAKE FOREST, IL
Drug identification
- Brand name(s)
- NALOXONE HYDROCHLORIDE
- Generic name(s)
- NALOXONE HYDROCHLORIDE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-1782- Route(s)
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS