The Recall Desk
CriticalFDA (Drugs)·D-0839-2018·Announced 2018-05-23

Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials

Apotex Inc. is recalling 121,693 vials of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.

Plain-English summary

Apotex Inc. is recalling 121,693 vials of Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial. The product is distributed nationwide in the USA. The recall is due to high levels of impurities that resulted in decreased potency of the drug.

The affected product is manufactured by Hospira Healthcare India Pvt. Ltd. for Apotex Corp. The recall covers specific lots with expiration dates ranging from May 2018 to September 2019. The product is a prescription-only medication available in 10-count single-use vials per carton.

Healthcare providers and patients should stop using the affected lots and contact Apotex Inc. for further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product
Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4
Manufacturer
Apotex Inc.
Category
Drug — Antibiotic Injection
Hazard
Affected units
121,693

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 (20)

  • Lots: 501G014 Exp. 05/2018
  • 501G015 Exp.09/2018
  • 501G016
  • 501G017
  • 501G018
  • 501G019
  • 501G020
  • 501G021
  • 501G022
  • 501G023 Exp. 10/2018
  • 501G024
  • 501G025
  • 501G026
  • 501G027
  • 501G028
  • 501G029 501G030
  • Exp. 11/2018
  • 501H001
  • 501H002
  • 501H003

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Apotex 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 2 products in this recall →

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