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Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J...

FDA Recall #D-1235-2019 — Class II — April 12, 2019

Recall #D-1235-2019 Date: April 12, 2019 Classification: Class II Status: Terminated

Product Description

Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Reason for Recall

Lack of sterility assurance.

Recalling Firm

CMC Enterprise Pharmacy — Charlotte, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

532 bags

Distribution

NC

Code Information

Lots: ED041918 Exp. 4/13/2019; ED051918 Exp. 4/14/2019; ED081918 Exp. 4/17/2019; ED091918 Exp. 4/18/2019; ED101918 Exp. 4/19/2019; ED111916 Exp. 4/20/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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