FDAClass IIJuly 11, 2018

Diltiazem HCL 1 mg/mL in recall: Sterility Concern

Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT

Why was Diltiazem HCL 1 mg/mL in recalled?

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

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?

Lot # 1218001315, 1218001316, 1218001349, 1218001416, 1218001510, 1218001682, 1218001683, 1218001684, 1218001721, 1218001763, 1218001764, Exp 07/26/2018-08/27/2018

Product
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
Recalling firm
SCA Pharmaceuticals, LLC
Quantity
2,869 bags
Distribution
Product was distributed throughout the United States.
Recall date
July 11, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls