Hydromorphone HCl Infusion Recall Due to Sterility Assurance
Family Pharmacy of Statesville is recalling one lot of Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags due to lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II drug recall involving a sterility defect in an injectable opioid infusion product. Lack of sterility assurance in an injectable medication presents a significant risk of serious infection, meeting the criteria for a Severe (4) classification.
Plain-English summary
Family Pharmacy of Statesville is recalling Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Lot #08022020@1 with a Beyond Use Date of 8/17/2020, distributed in North Carolina. The recall is due to lack of assurance of sterility.
Hydromorphone is a prescription opioid pain medication. When sterility cannot be assured, there is a risk that the product may be contaminated with harmful bacteria or other microorganisms.
Patients who have received this medication should contact their healthcare provider if they experience signs of infection or other adverse health effects. Healthcare facilities and patients in North Carolina should verify that they have not received units from this lot and should handle any affected product according to the recalling firm's instructions.
The recalled product
- Product
- Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- Category
- Drug — Injectable / Infusion
- Hazard
- sterility-defect
- bacterial-contamination
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 (1)
- Lot #: 08022020@1 BUD: 8/17/2020
Distribution
Distributed in 1 state:
- NC
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