Recalls / Class I
Class ID-0906-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Naloxone Hydrochloride
- Generic name
- Naloxone Hydrochloride
- Active ingredient
- Naloxone Hydrochloride
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDC
- 0409-1782
- FDA application
- ANDA070172
- Affected lot / code info
- 72680LL, Exp. 1DEC2018 (NDC 0409-1782-03); 76510LL, Exp. 1APR2019 (NDC 0409-1782-69)
Why it was recalled
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Recalling firm
- Firm
- HOSPIRA INC, LAKE FOREST
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 NORTH FOREST DRIVE, N/A, LAKE FOREST, Illinois 60045
Distribution
- Quantity
- 164,860 syringes
- Distribution pattern
- Nationwide in the U.S., Puerto Rico, and Guam
Timeline
- Recall initiated
- 2018-06-04
- FDA classified
- 2018-07-02
- Posted by FDA
- 2018-06-13
- Terminated
- 2020-03-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0906-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.