Hydromorphone HCl 5 mg/mL Infusion Recall Due to Sterility Assurance
Family Pharmacy of Statesville is recalling Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags because the manufacturer cannot assure the product meets sterility requirements.
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 recall of a sterile compounded injectable drug product where sterility cannot be assured. Loss of sterility in intravenous medications poses significant risk of serious infection and potential hospitalization, meeting the Severe criteria.
Plain-English summary
Family Pharmacy of Statesville, Inc. is recalling Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags (Lot #: 07292020@7, BUD: 8/12/2020) distributed in North Carolina. The product is being recalled due to lack of assurance of sterility.
Hydromorphone is a controlled opioid medication administered by infusion. A non-sterile intravenous product poses a risk of serious infection to patients who receive it.
Patients who have received this medication from the recalled lot should contact their healthcare provider. Healthcare providers who have this product in inventory should not use it and should contact Family Pharmacy of Statesville for instructions on disposal or return.
The recalled product
- Product
- Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- Category
- Drug — Compounded Injectable
- 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 #: 07292020@7 BUD: 8/12/2020
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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