CLASS I Drug recall · Reported 24 Jul 2013 · FDA Enforcement Report

Piperacillin and Tazobactam for Injection, USP per Pharmacy vial recalled

Apotex is recalling Piperacillin and Tazobactam for Injection, USP per Pharmacy vial, distributed nationwide in the US. The recall was initiated on 18 Mar 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: 503B015, 503B016, Exp 04/13; 503B019, 503B020, 503B021, 503B022, Exp 07/13; 503B024, Exp 08/13; 503B025, 503B026, 503B027, Exp 09/13; 503C005, 503C006, Exp 12/13; 503C007, 503C008, Exp 01/14; 503C018, Exp 04/14

Quantity recalled37,303 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-806-2013
FDA event ID: 64657
Recalling firm: Apotex, Weston, FL
Classification: Class I
Status: Terminated
Recall initiated: 18 Mar 2013
FDA classified: 17 Jul 2013
Reported: 24 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Antibiotics

Timeline

18 Mar 2013	Recall initiated by company
17 Jul 2013	Classified by FDA	+121 days
24 Jul 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

Which lots are affected?

Lot #: 503B015, 503B016, Exp 04/13; 503B019, 503B020, 503B021, 503B022, Exp 07/13; 503B024, Exp 08/13; 503B025, 503B026, 503B027, Exp 09/13; 503C005, 503C006, Exp 12/13; 503C007, 503C008, Exp 01/14; 503C018, Exp 04/14

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Piperacillin recalls

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Reported	Class	Recall	Company	Reason	Where
24 May 2023Drug	CLASS II	Piperacillin and Tazobactam for Injection, USP per vial recalled	Astral SteriTech Private	Sterility	Nationwide
24 May 2023Drug	CLASS II	Piperacillin and Tazobactam for Injection, USP per vial recalled	Astral SteriTech Private	Sterility	Nationwide
24 May 2023Drug	CLASS II	Piperacillin and Tazobactam for Injection, USP per vial recalled	Astral SteriTech Private	Sterility	Nationwide
24 May 2023Drug	CLASS II	Piperacillin and Tazobactam for Injection, UPS per vial recalled	Astral SteriTech Private	Sterility	Nationwide
24 May 2023Drug	CLASS II	Piperacillin and Tazobactam for Injection, USP per vial recalled	Astral SteriTech Private	Sterility	Nationwide