The Recall Desk
HighFDA (Drugs)·D-1249-2022·Announced 2022-07-27

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
Affected units
2,315

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.

Part of a larger recall action

This product is one of 37 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.

See all 37 products in this recall →

Related recalls

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · sterility assurance failure

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