Hospira Carpuject Recall Issued Due to Potential Leaks of Some Drug Products

Failure of the Carpuject injection seals may lead to the need for further medical treatment, the FDA warns.

The Pfizer subsidiary Hospira Inc. is recalling some of their injectable medications, following at least one complaint of leaks due to defective seals.

A Carpuject recall was announced by the U.S Food and Drug administration (FDA) on May 22, after discovering that prefilled syringes of the Buprenorphine Hydrochloride Injection and Labetalol Hydrochloride Injection may experience leaks

Carpujects are a ready-to-use prefilled syringe that allows for needle free access, it is made up of a calibrated glass drug vial and a plastic syringe. These devices help reduce medication errors, needle stick injuries, contamination, and decrease preparation time.

Buprenorphine HCl Injection is used to manage pain that needs an opioid painkiller when other treatments aren’t enough. It is a clear, sterile injection introduced either into a vein or a muscle. Labetalol HCl Injection is used to control high blood pressure in severe cases.

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The FDA warns that the recalled products have an increased risk of the medication not working properly and an increased risk of systematic infection if the seals fail, which could lead to the need of further medical treatment.

The Carpujects were distributed nation-wide to wholesalers and hospitals in the U.S from September 2023 until April 2024.

The affected Buprenorphine Hydrochloride Injections come in cartons with NDC 0409-2012-32 and cartridges with NDC 0409-2012-03. Lot number HJ3965 expires in September 2024 and contains 0.3 mg base/mL concentration, with 10 cartridge units per carton. Lot number HJ8546 expires in October 2024 and also contains 0.3 mg base/mL concentration, with 10 cartridge units per carton.

Labetalol Hydrochloride Injection comes in bundles with NDC 0409-2339-34 and cartons/cartridges with NDC 0409-2339-24. Lot number HJ7566 expires in May 2025 and contains 20 mg/4 mL (5 mg/mL) concentration, with 10 carton/cartridge units per bundle. Lot number HN8747 expires in September 2025 and also contains 20 mg/4 mL (5 mg/mL) concentration, with 10 carton/cartridge units per bundle. Lot number HN8749 also expires in September 2025 and contains 20 mg/4 mL (5 mg/mL) concentration, with 10 carton/cartridge units per bundle.

Wholesalers and hospitals with affected products should immediately stop using and distributing them, and should place the product in quarantine. They should also inform customers, and any other locations that might have received them, about the recall.

Healthcare professionals with questions about this recall can contact Pfizer for assistance. For medical questions regarding the product, they can reach Pfizer Medical Information at 800-438-1985, option 3, Monday through Friday from 9am to 5pm ET, or visit www.pfizermedinfo.com. To report adverse events and product complaints, contact Pfizer Drug Safety at 800-438-1985, option 1, available 24 hours a day, 7 days a week.

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