FDA recall D-806-2013

Product

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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-03-18

Report date

2013-07-24

Termination date

2018-01-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-806-2013