Hydromorphone HCl Infusion Bags Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Hydromorphone HCl 2 mg/mL Infusion 250 mL bags (2 units) distributed in North Carolina 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 recall of a sterile injectable pharmaceutical product (hydromorphone). Class II recalls with potential for serious adverse health consequences, such as infection from a non-sterile injectable, meet the Severe threshold even absent reported illnesses.
Plain-English summary
Family Pharmacy of Statesville, Inc. is recalling Hydromorphone HCl 2 mg/mL Infusion 250 mL bags due to lack of assurance of sterility. The affected product consists of 2 bags with lot number 07212020@4 (BUD 10/19/2020 and BUD 10/30/2020) distributed in North Carolina.
Hydromorphone HCl is an opioid medication intended for intravenous infusion. A lack of sterility assurance in injectable pharmaceutical products presents a risk of infection if the product is administered.
Patients who have received this product should contact their healthcare provider. Healthcare providers should inform patients of the recall and advise them to monitor for signs of infection.
The recalled product
- Product
- Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- Category
- Drug — Injectable / Infusion
- Affected units
- 2
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 #: 07212020@4 BUD: 10/19/2020
- 07212020@4 BUD: 10/30/2020
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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