Why it was recalled
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
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
Lot numbers, UPCs & expiration codes
72680LL, Exp. 1DEC2018 (NDC 0409-1782-03); 76510LL, Exp. 1APR2019 (NDC 0409-1782-69)
Where it was sold
Nationwide in the U.S., Puerto Rico, and Guam
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0906-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 4, 2018
- FDA report date
- Jun 13, 2018
- Quantity
- 164,860 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- HOSPIRA INC, LAKE FOREST
Original FDA data
Every field from FDA enforcement report D-0906-2018, exactly as published.
Show all FDA fields
- City
- LAKE FOREST
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80167
- Address
- 275 NORTH FOREST DRIVE
- Code information
- 72680LL, Exp. 1DEC2018 (NDC 0409-1782-03); 76510LL, Exp. 1APR2019 (NDC 0409-1782-69)
- Postal code
- 60045
- Report date
- Jun 13, 2018
- Product type
- Drugs
- Recall number
- D-0906-2018
- Classification
- Class I
- Recalling firm
- HOSPIRA INC, LAKE FOREST
- Product quantity
- 164,860 syringes
- Termination date
- Mar 27, 2020
- Reason for recall
- Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the U.S., Puerto Rico, and Guam
- Recall initiation date
- Jun 4, 2018
- Initial firm notification
- Press Release
- Center classification date
- Jul 2, 2018