FDAClass IIDecember 24, 2014

Meropenem I.V recall: Sterility Concern

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…

Why was Meropenem I.V 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Hospira Inc.
Quantity
261,706 vials
Distribution
Nationwide and Puerto Rico, Italy, Netherland, Spain
Recall date
December 24, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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