Recall archive / FDA company announcement
Hospira: Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject U... — FDA announcement May 22, 2024
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date May 22, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units
- Reason
- Device & Drug Safety – Potential Packaging Defect
- Classification
- Not supplied
- Recalling firm
- Hospira Inc.
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 19fd9c0e6b97e8de
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | The NDC, Lot Number, Expiration Date, and Configuration details for the impacted products are indicated below. The products were distributed nationwide to wholesalers/hospitals in the United States from September 2023 through April 2024.; Product | NDC | Lot Number | Expiration Date | Concentration | Configuration/ Count; Buprenorphine Hydrochloride Injection – CIII CarpujectTM Single-dose Cartridge/Tube Unit with Luer Lock | Carton 0409-2012-32 Cartridge 0409-2012-03 | HJ3965 | 2024/09 | 0.3 mg base/mL | 10 cartridge units/carton; HJ8546 | 2024/10 | 0.3 mg base/mL | 10 cartridge units/carton; Labetalol Hydrochloride Injection, USP CarpujectTM Single-dose Cartridge Unit with Luer Lock | Bundle 0409-2339-34 Carton/Cartridge 0409-2339-24 | HJ7566 | 2025/05 | 20 mg/4 mL (5 mg/mL) | 10 carton/ cartridge units/bundle; HN8747 | 2025/09 | 20 mg/4 mL (5 mg/mL) | 10 carton/ cartridge units/bundle; HN8749 | 2025/09 | 20 mg/4 mL (5 mg/mL) | 10 carton/ cartridge units/bundle; Contact Center | Contact Information | Area of Support; Pfizer Medical Information | 800-438-1985, option 3 (Mon.-Fri. 9am – 5pm ET) www.pfizermedinfo.com | For medical questions regarding the product; Pfizer Drug Safety | 800-438-1985, option 1 (24 hours a day; 7 days a week) | To report adverse events and product complaints |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| Product | NDC | Lot Number | Expiration Date | Concentration | Configuration/ Count |
|---|---|---|---|---|---|
| Buprenorphine Hydrochloride Injection – CIII CarpujectTM Single-dose Cartridge/Tube Unit with Luer Lock | Carton 0409-2012-32 Cartridge 0409-2012-03 | HJ3965 | 2024/09 | 0.3 mg base/mL | 10 cartridge units/carton |
| HJ8546 | 2024/10 | 0.3 mg base/mL | 10 cartridge units/carton | ||
| Labetalol Hydrochloride Injection, USP CarpujectTM Single-dose Cartridge Unit with Luer Lock | Bundle 0409-2339-34 Carton/Cartridge 0409-2339-24 | HJ7566 | 2025/05 | 20 mg/4 mL (5 mg/mL) | 10 carton/ cartridge units/bundle |
| HN8747 | 2025/09 | 20 mg/4 mL (5 mg/mL) | 10 carton/ cartridge units/bundle | ||
| HN8749 | 2025/09 | 20 mg/4 mL (5 mg/mL) | 10 carton/ cartridge units/bundle |
| Contact Center | Contact Information | Area of Support |
|---|---|---|
| Pfizer Medical Information | 800-438-1985, option 3 (Mon.-Fri. 9am – 5pm ET) www.pfizermedinfo.com | For medical questions regarding the product |
| Pfizer Drug Safety | 800-438-1985, option 1 (24 hours a day; 7 days a week) | To report adverse events and product complaints |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
The NDC, Lot Number, Expiration Date, and Configuration details for the impacted products are indicated below. The products were distributed nationwide to wholesalers/hospitals in the United States from September 2023 through April 2024. Wholesalers and hospitals with an existing inventory of any of the lots which are being recalled should discontinue use, stop distribution, and quarantine the product immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Sedgwick at 800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Fda listing date
- May 22, 2024
- Company announcement date
- May 21, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.