Previously on the blog, we alerted you to two Hospira Carpuject products that were recalled due to excessive fill volume: one lot (10830LL) of morphine sulfate Carpuject syringes and one lot (07547LL) of hydromorphone Carpuject syringes.
The FDA has now issued an additional alert regarding ALL Hospira Carpuject syringes. Subsequent inspection of retained product by Hospira found additional overfilled Carpuject pre-filled cartridges. The manufacturing problem thought to be responsible for this overfilling has resulted in the risk for overfill for as many as 280 lots of 15 different Carpuject pre-filled cartridge products. The pre-filled cartridges containing the products listed below may be overfilled by at least twice the expected amount, resulting in potential overdose.
Potentially affected Hospira Carpuject products include the following:
• Demerol (meperidine) injection
• Diazepam injection
• Fentanyl citrate injection
• Heparin lock flush solution
• Heparin sodium injection
• Hydromorphone injection
• Ketorolac injection
• Labetalol injection
• Lorazepam injection
• Metoprolol tartrate injection
• Midazolam injection
• Morphine injection
• Naloxone injection
• Ondansetron injection
• Sodium chloride injection
The FDA recommends that healthcare providers visually inspect and confirm that the Carpuject pre-filled cartridge contains the labeled fill volume before dispensing and again before administering to patients. If a Carpuject pre-filled cartridge contains a greater volume of medication than described by the label, healthcare providers should not use the product and should return it to Hospira. The FDA is recommending this measure rather than a product recall, because a recall of the affected products would result in an immediate shortage. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program (www.fda.gov/MedWatch/report.htm).
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