Ketamine 50 mg Infusion Solution Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling three bags of Ketamine 50 mg Infusion Solution 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: The FDA classified this as Class II. A lack of sterility assurance in an intravenous medication poses significant risk of infection and serious patient harm, meeting the threshold for Severe classification even absent reported illnesses.
Plain-English summary
Family Pharmacy of Statesville, Inc. is recalling Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags due to lack of assurance of sterility. The affected product consists of three bags with the following lot numbers and beyond-use dates: Lot #07212020@1 (BUD 8/4/2020), Lot #07232020@2 (BUD 8/6/2020), and Lot #07302020@2 (BUD 8/13/2020).
The recalled product was distributed in North Carolina only. Ketamine is a prescription medication used for anesthesia and other medical purposes. Without assured sterility, there is a risk of microbial contamination that could cause serious harm to patients who receive the infusion.
Patients who have received or may have received doses from the recalled lots should contact their healthcare provider immediately. Healthcare providers who dispensed this product should also be notified of the recall.
The recalled product
- Product
- Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- Category
- Drug — Intravenous Infusion
- Hazard
- sterility-failure
- microbial-contamination
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 #: 07212020@1 BUD: 8/4/2020
- 07232020@2 BUD: 8/6/2020
- 07302020@2 BUD: 8/13/2020
Distribution
Distributed in 1 state:
- NC
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