Compounded Injectable Medications Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 2,315 pre-filled syringes due to lack of sterility assurance. The compounded injectable medication 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 for injectable medications involving lack of sterility assurance. The source text does not report illnesses or injuries, and the hazard is not confirmed contamination but rather a failure of sterility assurance processes. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling 2,315 pre-filled syringes of compounded injectable medication distributed nationwide. The product contains Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), and Ketamine HCl 60 mg (1.2 mg/mL).
The recall is due to lack of assurance of sterility. Nephron cannot confirm that the affected medication lots meet required sterility standards.
The affected lots are: BP2001A (expiration 7/6/2022), BP2002A (expiration 7/27/2022), and BP2007A (expiration 7/3/2022). Healthcare providers and facilities in possession of these lots should not use them.
The recalled product
- Product
- Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. E
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-assurance-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 (6)
- Lots: BP2001A
- Exp. 7/6/2022
- BP2002A
- Exp. 7/27/2022
- BP2007A
- Exp. 7/3/2022
Distribution
Distributed nationwide across the United States.
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