D-0906-2018 Class I Terminated
FDA drug recall D-0906-2018 was initiated by HOSPIRA INC, LAKE FOREST on Jun 4, 2018 and is designated Class I. Reason for recall: Presence of Particulate Matter; Potential for particulate matter on the syringe plunger. The recall status is terminated (terminated Mar 27, 2020). Affected quantity: 164,860 syringes.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 13, 2018
- Initiation Date
- Jun 4, 2018
- Termination Date
- Mar 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 164,860 syringes
Product description
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.
Distribution pattern
Nationwide in the U.S., Puerto Rico, and Guam
Code information
72680LL, Exp. 1DEC2018 (NDC 0409-1782-03); 76510LL, Exp. 1APR2019 (NDC 0409-1782-69)
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0906-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026