Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pfizer Inc., originally initiated on 05-20-2024 for the product Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24 The product was recalled due to lack of assurance of sterility-the potential for incomplete crimp seals.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0565-2024 | 05-20-2024 | 07-03-2024 | Class II | 220,400 cartridges | Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24 | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Ongoing |
| D-0564-2024 | 05-20-2024 | 07-03-2024 | Class II | 84,710 cartridges | Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03 | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0409-2012 | Buprenorphine Hydrochloride | Buprenorphine Hydrochloride | Injection, Solution | Intramuscular; Intravenous | Hospira, Inc. | Human Prescription Drug |
| 0409-2339 | Labetalol Hydrochloride | Labetalol Hydrochloride | Injection, Solution | Intravenous | Hospira, Inc. | Human Prescription Drug |
