Ketamine Hydrochloride Injectable Recalled Due to Sterility Assurance Issues
Nephron Sterile Compounding Center LLC is recalling 30,290 syringes of Ketamine Hydrochloride Injection due to lack of assurance of sterility. The injectable drug was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—lack of sterility assurance in an injectable drug—represents a theoretical risk to patient safety. Per the rubric, this qualifies as High (Score 3) for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Ketamine Hydrochloride Injection, USP 30 mg/3 mL supplied in 3 mL pre-filled syringes. The affected lot is KH2008A, which expired 8/8/2022. A total of 30,290 syringes are included in the recall. The product was distributed nationwide in the United States.
The recall was issued due to lack of assurance of sterility in the affected lot. Sterility is essential for injectable medications, as contaminated injectables could pose serious health risks to patients.
The recalled product
- Product
- Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable Medication
- Affected units
- 30,290
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: KH2008A
- Exp. 8/8/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Nephron Sterile Compounding Center LLC 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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