PlainRecalls
FDA Drug Moderate Class II Terminated

Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

Reported: September 5, 2018 Initiated: August 21, 2018 #D-1157-2018

Product Description

Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

Reason for Recall

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Details

Recalling Firm
Auro Pharmacies, Inc.
Units Affected
167 vials
Distribution
Nationwide in USA
Location
La Habra, CA

Frequently Asked Questions

What product was recalled?
Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631. Recalled by Auro Pharmacies, Inc.. Units affected: 167 vials.
Why was this product recalled?
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 5, 2018. Severity: Moderate. Recall number: D-1157-2018.