Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80063

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 08, 2018
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Apotex Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-0839-2018
Recall number
D-0839-2018
Initiated
May 08, 2018
Classification
Class I
Status
Terminated
Recalling firm
Apotex Inc.
Quantity
121693 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Code information

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, 501H004, 501H005, 501H006, 501H007, 501H008, Exp. 12/2018; 501H009, Exp. 04/2019; 501H012, 501H013 Exp. 06/2019; 501H018, 501H019, Exp. 09/2019.

Distribution pattern

Nationwide in the USA.

drug · product 2 of 2

Piperacillin and Tazobactam for Injection, USP 4.5 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 60505-0688-4

D-0840-2018
Recall number
D-0840-2018
Initiated
May 08, 2018
Classification
Class I
Status
Terminated
Recalling firm
Apotex Inc.
Quantity
13453 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Code information

Lots: 502H001 Exp. 01/2019; 502H003, 502H004, 502H005, Exp. 04/2019; 502H009, 502H012, Exp. 05/2019.

Distribution pattern

Nationwide in the USA.