Lorazepam 1 mg/mL Infusion Solution Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Lorazepam 1 mg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure sterility of the product.
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 involving a sterility failure in an injectable medication. Lack of sterility assurance in intravenous medications poses significant risk of serious infection and potential hospitalization, meeting the threshold for Severe (score 4) even though no illnesses have been explicitly reported in the source text.
Plain-English summary
Family Pharmacy of Statesville is recalling one lot of Lorazepam 1 mg/mL Infusion Solution in 250 mL bags (Lot #07312020@6, BUD 8/7/2020) distributed in North Carolina. The recall is due to lack of assurance of sterility.
Lorazepam is a prescription medication used for sedation and anxiety management. Non-sterile infusion solutions pose a risk of infection to patients who receive them intravenously. Patients who have received this product should consult their healthcare provider about potential exposure.
Consumers or healthcare providers who have this product should stop using it and contact Family Pharmacy of Statesville or their healthcare provider for guidance. The affected lot is limited to the single identified lot number with expiration of 8/7/2020.
The recalled product
- Product
- Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- 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 #: 07312020@6 BUD: 8/7/2020
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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