May 2013 FDA Recall Drug by Apotex Corp.
D-835-2013 - Crystallization

This Class I drug recall was voluntarily initiated by Apotex Corp. on May 10, 2013 for the product Drug. The FDA reported the reason for recall as crystallization. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-835-2013

Reason for Recall
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Initiated
05-10-2013
Reported
08-14-2013
Quantity
52,398 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65196
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot No. 503B023, Exp. 08/13; 503B028, 503B029, 503B030, 503B031, 503B032, 503B033, Exp. 11/13; 503C001, 503C002, 503C003, 503C004, Exp. 12/13; 503C009, Exp. 01/14; 503C010, 503C011, 503C012, 503C014, Exp. 02/14; 503C015, 503C016, 503C017, 503C019, 503C020, Exp. 04/14