Agency classClass IOur severity:Critical FDA (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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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: subpotent-drug
impurities
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 →

Same manufacturer · Apotex Inc.

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Same hazard · subpotent drug