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
Product summary
- 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
Particulate Matter