FDAClass IIFebruary 3, 2016

ZOSYN (pipericillin/tazobactam) in NS recall: Sterility Concern

ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

Why was ZOSYN (pipericillin/tazobactam) 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) 1-Oct-15 b) 28-Sep-15 c) 25-Sep-15, 29-Sep-15, d) 26-Sep-15, 29-Sep-15 e) 1-Oct-15

Product
ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Recalling firm
Sentara Enterprises
Quantity
a) 56 Bags b) 28 Bags c) 4 Bags, d) 10 Bags e) 2 Bags
Distribution
U.S. Including: VA, NC
Recall date
February 3, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls