FDAClass IIFebruary 3, 2016

Meropenem in NS recall: Sterility Concern

MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence…

Why was Meropenem in NS recalled?

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

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?

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 18-Sep-15, 20-Sep-15, 21-Sep-15, 22-Sep-15, 23-Sep-15, 24-Sep-15 b) 16-Sep-15, 19-Sep-15, 21-Sep-15

Product
MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence…
Recalling firm
Sentara Enterprises
Quantity
a) 159 Bags b) 33 Bags
Distribution
U.S. Including: VA, NC
Recall date
February 3, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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