FDAClass IIMay 1, 2019

CeFAZolin 1 GM a) in NS recall: Sterility Concern

CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC…

Why was CeFAZolin 1 GM a) in NS 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: a) ED051904 Exp. 4/14/2019; ED081903 Exp. 4/17/2019; ED091903 Exp. 4/18/2019; ED111903 Exp. 4/20/2019; b) EB271904 Exp. 4/13/2019; EB281904 Exp. 4/14/2019; EC011903 Exp. 4/15/2019; EC051904 Exp. 4/19/2019; EC071904 Exp. 4/21/2019; EC081905 Exp. 4/22/2019; EC121905 Exp. 4/26/2019; EC131903 Exp. 4/27/2019; EC141903 Exp. 4/28/2019; EC151903 Exp. 4/29/2019; EC181904 Exp. 5/2/2019; EC191905 Exp. 5/3/2019; EC211904 Exp. 5/5/2019; EC221905 Exp. 5/6/2019; EC251904 Exp. 5/9/2019; EC271904 Exp. 5/11/2019; EC281904 Exp. 5/12/2019; ED011904 Exp. 5/16/2019; ED021906 Exp. 5/17/2019; ED031904 Exp. 5/18/2019; ED041903 Exp. 5/19/2019; ED051905 Exp. 5/20/2019; ED081904 Exp. 5/23/2019; ED091904 Exp. 5/24/2019; ED101904 Exp. 5/25/2019; ED111904 Exp. 5/26/2019

Product
CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC…
Recalling firm
CMC Enterprise Pharmacy
Quantity
a) 150 bags; b)1369 syringes
Distribution
NC
Recall date
May 1, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls