The Recall Desk
HighFDA (Drugs)·D-0763-2023·Announced 2023-05-31

Nafcillin Injectable Medication Recalled for Sterility Assurance Failure

Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP 2 gram vials nationwide due to lack of assurance of sterility in the manufacturing process. This FDA Class II recall affects multiple lots distributed across the United States.

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 FDA Class II recall involves a sterility assurance issue with an injectable medication, which presents a risk of harm to patients should the product be contaminated. No illnesses or injuries have been reported. Under the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High severity score.

Plain-English summary

Sagent Pharmaceuticals Inc is recalling Nafcillin for Injection, USP, 2 gram per vial (NDC 25021-140-10) due to lack of assurance of sterility. Approximately 2,249,980 vials have been distributed nationwide.

The affected lots are: NFL101 and NFL102 (expiration date 1/31/2024), NFL103 and NFL104 (expiration date 5/31/2024), NFL201 (expiration date 3/31/2025), and NFL202 (expiration date 5/31/2025).

Healthcare providers and patients using Nafcillin from the affected lots should consult with their healthcare provider regarding their treatment. Consumers should stop using the recalled product from the specified lots and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Manufacturer
Sagent Pharmaceuticals Inc
Category
Drug — Injectable / Parenteral
Hazard
Affected units
2,249,980

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 (10)

  • Lots: NFL101
  • NFL102
  • EXP: 1/31/2024
  • Lots: NFL103
  • NFL104
  • EXP: 5/31/2024
  • Lot: NFL201
  • EXP: 03/31/2025
  • Lot: NFL202
  • EXP: 5/31/2025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Sagent Pharmaceuticals Inc 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 3 products in this recall →

Related recalls

Same manufacturer · Sagent Pharmaceuticals Inc

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Same hazard · sterility failure

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