Recalls / Class II

Class IID-0303-2015

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

Affected lot / code info

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

Why it was recalled

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.

Recalling firm

Firm

Hospira Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579

Distribution

Quantity

261,706 vials

Distribution pattern

Nationwide and Puerto Rico, Italy, Netherland, Spain

Timeline

Recall initiated

2014-10-24

FDA classified

2014-12-18

Posted by FDA

2014-12-24

Terminated

2016-12-15

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0303-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.