October 2014 FDA Recall Drug by Hospira Inc.
D-0303-2015 - Defective Container

This Class II drug recall was voluntarily initiated by Hospira Inc. on October 24, 2014 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0303-2015

Reason for Recall
Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
Initiated
10-24-2014
Reported
12-24-2014
Quantity
261,706 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69798
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hospira Inc.
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 and Puerto Rico, Italy, Netherland, Spain
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-15-2016
Product Description About Product Description
Full technical description of the product.
Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01

Batch or Lot Expiration Information

Lot# : 609E014, Exp 1/2016; 609E015, Exp 1J/2016; 609E016, Exp 1/2016; 609E017, Exp 1/2016; 609E018, Exp 1/2016; 609E019, Exp 1/2016; 601E025, Exp 1/2016; 601E027, Exp 1/2016; 601E028A, Exp 1/2016; 601E028B, Exp 1/2016; 601E028C, Exp 1/2016