FDAClass IIMay 1, 2019

NICARdipine 25 mg in NS recall: Sterility Concern

NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Why was NICARdipine 25 mg 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: EA161909 Exp. 4/16/2019; EA211907 Exp. 4/21/2019; EB041906 Exp. 5/5/2019; EB111908 Exp. 5/12/2019; EB181907 Exp. 5/19/2019; EB251910 Exp. 5/26/2019; EC111908 Exp. 6/9/2019; EC201909 Exp. 6/18/2019; EC261909 Exp. 6/24/2019; EC271919 Exp. 6/25/2019

Product
NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Recalling firm
CMC Enterprise Pharmacy
Quantity
1783 bags
Distribution
NC
Recall date
May 1, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls