Ketamine HCl Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Ketamine HCl Injection due to lack of sterility assurance. The recall affects 91,445 pre-filled syringes 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 of a sterile injectable drug with a control/testing failure (lack of sterility assurance). No illnesses or hospitalizations are reported, but the potential for serious infection from microbial contamination of an injectable product justifies a High rating per the rubric.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Ketamine HCl Injection, USP, 50 mg/5 mL pre-filled syringes due to lack of assurance of sterility. The affected lots are KH2006A, KH2006B, and KH2012B, with expiration dates of 7/20/2022 and 8/23/2022. The product NDC is 69374-982-55.
The recall encompasses 91,445 syringes packaged as 5 x 5 mL pre-filled syringes per carton, with 6 x 5 syringe cartons per case. The product was manufactured by Nephron Sterile Compounding Center LLC at their 503B outsourcing facility located at 4500 12th St. Extension, West Columbia, South Carolina 29172.
The affected product was distributed nationwide throughout the United States. This is a prescription-only injectable medication.
The recalled product
- Product
- Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Hazard
- sterility-failure
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 (5)
- Lots: KH2006A
- Exp. 7/20/2022
- KH2006B
- KH2012B
- Exp. 8/23/2022
Distribution
Distributed nationwide across the United States.
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