Hospira Recalls Morphine Sulfate Injection Cartridges Due to Overfilling
Hospira Inc. is recalling Morphine Sulfate Injection cartridges that contain 2.2 mL instead of the labeled 1 mL, posing a risk of overdose.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Hospira Inc. is recalling Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Units. The recall involves Lot #10830LL with an expiration date of April 1, 2013. The product is distributed nationwide and is identified by NDC 0409-1258-30.
The recall was initiated because the cartridges were found to contain 2.2 mL of solution instead of the labeled 1 mL. This discrepancy results in a superpotent product, meaning the actual concentration or volume exceeds the labeled amount, which can lead to an unintended overdose if administered as prescribed.
Healthcare providers and patients should stop using the affected cartridges immediately. The recall is classified as FDA Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 212,370
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #10830LL
- Exp. 1APR2013
Distribution
Distributed nationwide across the United States.
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