Hospira Recalls Overfilled Hydromorphone Hydrochloride Prefilled Cartridges
Hospira Inc. is recalling 223,750 units of Hydromorphone Hydrochloride Injection because some prefilled cartridges contain more than the labeled 1 mL volume.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Hospira Inc. is recalling 223,750 prefilled cartridge units of Hydromorphone Hydrochloride Injection, USP, 1 mg/mL. The affected product is packaged in 10-count Carpujects per carton and is identified by Lot #07547LL with an expiration date of 07/01/13. The product is distributed nationwide.
The recall was initiated because some of the prefilled cartridge units were found to be overfilled, containing more than the 1 mL labeled fill volume. This is classified as a Class I recall by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
Healthcare providers and pharmacies should stop using the affected product and return it to Hospira Inc. Patients should consult their healthcare provider if they have questions regarding the use of this medication.
The recalled product
- Product
- HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
- Brand
- HYDROMORPHONE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 223,750
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 #07547LL
- Exp 07/01/13
Distribution
Distributed nationwide across the United States.
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