Hospira Recalls Overfilled Hydromorphone Hydrochloride Injection Cartridges
Hospira is recalling 216,880 units of Hydromorphone Hydrochloride Injection because the prefilled cartridges were found to be overfilled, containing 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 recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Hospira Inc. is recalling 216,880 units of Hydromorphone Hydrochloride Injection, USP, 2 mg/mL. The product is packaged in 1 mL fill Carpuject prefilled cartridge units, with 10 cartridges per carton. The specific lot affected is 12720LL, with an expiration date of 12/01/13. The product is distributed nationwide.
The recall was initiated because the prefilled cartridge units were found to be overfilled, containing more than the 1 mL labeled fill volume. This is classified as a Superpotent (Single Ingredient) Drug recall. The product is a prescription-only medication intended for intramuscular, intravenous, or subcutaneous use.
Healthcare providers and patients should stop using the affected lot and return the product to the distributor or contact Hospira for instructions. The recall is classified as FDA Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
- Brand
- HYDROMORPHONE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 216,880
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 12720LL
- Exp 12/01/13
Distribution
Distributed nationwide across the United States.
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