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.
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 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.
Related recalls
Same brand · HYDROMORPHONE HYDROCHLORIDE
- SeverePfizer Recalls Hydromorphone Hydrochloride Injection Vials Due to Non-Sterility
FDA (Drugs) · 2018-03-21
- CriticalPfizer Recalls Hydromorphone Hydrochloride Injection Due to Non-Sterility Concerns
FDA (Drugs) · 2018-03-21
- SeverePfizer Recalls Hydromorphone Hydrochloride Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2017-09-27
- ModerateHospira Recalls Hydromorphone Hydrochloride Injection Due to Silicone Oil Particulates
FDA (Drugs) · 2017-08-16
- ModerateHospira Recalls Hydromorphone Hydrochloride Injection Due to Silicone Oil Particulates
FDA (Drugs) · 2017-08-16
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16
Same hazard · overfill
See all →- ModerateBD Vacutainer Plus Plastic Citrate Blood Collection Tubes Recalled for Overfill
FDA (Devices) · 2018-06-27
- ModerateBD Vacutainer Plus Plastic Citrate Blood Collection Tubes Recalled for Overfill
FDA (Devices) · 2018-06-27
- ModerateBD Vacutainer Plus Plastic Citrate Blood Collection Tubes Recalled for Overfill
FDA (Devices) · 2018-06-27
- SevereFresenius Liberty Select Cycler Recalled for Software Overfill Risk
FDA (Devices) · 2018-04-18
- HighFresenius Liberty Cycler Peritoneal Dialysis Machines Recalled for Door Latch Defect
FDA (Devices) · 2016-02-03
Similar recalls
- CriticalHospira Recalls Overfilled Hydromorphone Hydrochloride Injection Cartridges
FDA (Drugs) · 2012-10-31
- CriticalHospira Recalls Morphine Sulfate Injection Cartridges Due to Overfilling
FDA (Drugs) · 2012-07-25
- HighHospira Recalls Hydromorphone Hydrochloride Injection Due to Broken Vials
FDA (Drugs) · 2014-10-29
- ModerateHospira Recalls Hydromorphone Hydrochloride Injection Due to Silicone Oil Particulates
FDA (Drugs) · 2017-08-16
- ModerateHospira Recalls Buprenorphine Hydrochloride Injection Due to Impurity Failure
FDA (Drugs) · 2014-10-01
- SeverePfizer Recalls Hydromorphone Hydrochloride Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2017-09-27