FDAClass IIJuly 17, 2013

Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as recall: Particulate Matter

Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by…

Why was Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as recalled?

Presence of Particulate Matter: visible particles were identified floating in the primary container.

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 07-067-DK Exp. 07/13

Product
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by…
Recalling firm
Hospira Inc.
Quantity
168,300 vals
Distribution
Nationwide
Recall date
July 17, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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