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U.S. Department of Health and Human Services

Drugs

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FDA advises healthcare providers to visually inspect Hospira Carpuject pre-filled cartridges for overfill

[5-23-2012] FDA is alerting healthcare providers of a potential safety risk in some Carpuject pre-filled cartridges manufactured by Hospira, Inc.  The pre-filled cartridges containing the products listed below may be overfilled by at least twice the expected amount, resulting in potential overdose.

FDA is advising healthcare providers to follow the instructions provided with the medication and visually inspect and confirm that the Carpuject pre-filled cartridge contains the labeled fill volume before dispensing and again before administering to patients.

Pre-filled cartridges for the following Hospira Carpuject products should be visually inspected for the possibility of overfill:

Product Name

Strength

Presentation

Demerol (meperidine HCl) Injection, USP

25 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

 

50 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

 

75 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

Diazepam Injection, USP

5 mg/mL

2 mL in 2.5 mL Carpuject, Luer Lock

Fentanyl Citrate Injection, USP

100 mcg Fentanyl/2 mL

2 mL in 2.5 mL Carpuject, Luer Lock

Heparin Lock Flush Solution, USP

10 USP heparin units/mL

1 mL in 2.5 mL Carpuject, Luer Lock

 

100 USP heparin units/mL

1 mL in 2.5 mL Carpuject, Luer Lock

 

100 USP heparin units/mL

3 mL in 5 mL Carpuject, Luer Lock

 

10 USP heparin units/mL

5 mL in 5 mL Carpuject, Luer Lock

 

100 USP heparin units/mL

5 mL in 5 mL Carpuject, Luer Lock

Heparin Sodium Injection, USP

5,000 USP heparin units/mL

1 mL in 2.5 mL Carpuject, Luer Lock

 

10,000 USP heparin units/mL

0.5 mL in 2.5 mL Carpuject, Luer Lock

HYDROmorphone HCl Injection, USP

1 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

 

2 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

 

4 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

Ketorolac Tromethamine Injection, USP

30 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

Labetalol Hydrochloride Injection, USP

20 mg/4 mL (5 mg/mL)

4 mL in 5 mL Carpuject, Luer Lock

Lorazepam Injection, USP

2 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

Metoprolol Tartrate Injection, USP

1 mg/mL

5 mL in 5 mL Carpuject, Luer Lock

Midazolam Injection, USP

2 mg/2 mL (1 mg/mL), Preservative-Free

2 mL in 2.5 mL Cartridge, iSecure Version 2

 

2 mg/2 mL (1 mg/mL), Preservative-Free

2 mL in 2.5 mL Carpuject, Luer Lock

Morphine Sulfate Injection, USP

4 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

 

8 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

 

10 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

 

15 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

Naloxone Hydrochloride Injection, USP

0.4 mg/mL

1 mL in 2.5 mL Carpuject, Luer Lock

Ondansetron Injection, USP

2 mg/mL

2 mL in 2.5 mL Cartridge, iSecure Version 2

Sodium Chloride Injection, USP

0.90%

2 mL in 2.5 mL Carpuject, Luer Lock

 

0.90%

3 mL in 5 mL Carpuject, Luer Lock

 

0.90%

5 mL in 5 mL Carpuject, Luer Lock

If a Carpuject pre-filled cartridge contains a greater volume of medication than described by the label, healthcare providers should not use the Carpuject pre-filled cartridge and should return it to Hospira.

Hospira, Inc. has informed the FDA of the occurrence of overfilled Carpuject pre-filled cartridges containing morphine and hydromorphone following complaints received from healthcare providers.

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 overfilled Carpuject pre-filled cartridges for as many as 280 lots of 15 different Carpuject pre-filled cartridge products.

However, according to the firm’s investigation, the number of Carpuject pre-filled cartridges in a lot that may contain an overfill appears to be low.

Because pharmacists and other healthcare providers can visually identify the presence of an overfilled Carpuject pre-filled cartridge, FDA is recommending that these steps be taken at this time rather than a product recall, because a recall of the affected products listed above would result in an immediate shortage.  FDA is still evaluating whether additional steps are necessary.

Healthcare professionals and patients are encouraged to report overfilled Carpuject pre-filled cartridges to the FDA’s MedWatch Safety Information and Adverse Event Reporting program.

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

The FDA remains vigilant in monitoring adverse event reports and is requesting pharmacists and other health care providers to be extra cautious in prescribing and dispensing all products.