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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 1
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:
Part of a larger recall action
This product is one of 12 recalled by Family Pharmacy of Statesville under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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