FDAClass IIMay 1, 2019

Vancomycin 2000 mg in 0.9% Sodium Chloride recall: Sterility Concern

Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Why was Vancomycin 2000 mg in 0.9% Sodium Chloride recalled?

Lack of sterility assurance.

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?

Lots: ED041919 Exp. 4/13/2019; ED051919 Exp. 4/14/2019; ED041919 Exp. 4/17/2019; ED091919 Exp. 4/18/2019; ED101919 Exp. 4/19/2019; ED111917 Exp. 4/20/2019

Product
Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Recalling firm
CMC Enterprise Pharmacy
Quantity
532 bags
Distribution
NC
Recall date
May 1, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls