Hydromorphone HCl 1 mg/mL 250 mL Bags Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling four bags of Hydromorphone HCl 1 mg/mL (250 mL each) distributed in North Carolina due to lack of assurance of sterility. The affected lots have beyond-use dates of October 25–30, 2020.
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 recall. Lack of sterility assurance in injectable medications creates a direct risk of infection, which is a serious health hazard. Although no illnesses have been reported in the source text, the hazard nature (injectable contamination risk) and the Class II classification together warrant a Severe rating.
Plain-English summary
Family Pharmacy of Statesville, Inc. is recalling Hydromorphone HCl 1 mg/mL 250 mL bags (Rx only) because the manufacturer cannot assure sterility of the product. The recall involves four bags with lot numbers 07272020@2, 07302020@1, and 08012020@1, with beyond-use dates of October 25, 28, and 30, 2020, respectively.
The affected product was distributed in North Carolina only. Hydromorphone is a prescription opioid medication. Lack of sterility assurance in injectable medications poses a risk of infection if the product is used.
Patients or healthcare providers in possession of the affected lots should not use this medication and should contact their pharmacy. Patients should consult with their healthcare provider about obtaining a replacement prescription if needed.
The recalled product
- Product
- Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- Category
- Drug — Injectable / Opioid
- Affected units
- 4
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 (3)
- Lot #: 07272020@2 BUD: 10/25/2020
- 07302020@1 BUD: 10/28/2020
- 08012020@1 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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