FDA-Drug2018-09-05Class II

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

Auro Pharmacies, Inc.
Hazard

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

Sold states
Nationwide in USA
Affected count
167 vials
Manufactured in
520 W La Habra Blvd, N/A, La Habra, CA, United States
Products
Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1157-2018

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