Calcium Gluconate injectable recalled over sterility concerns
- Recall date
- August 21, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Auro Pharmacies, Inc. recalls Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra…
- Recall number
- D-1157-2018
- FDA classification
- Class II
- Brand / firm
- Auro Pharmacies, Inc.
- Sold / distributed
- Nationwide in USA
Why it was recalled
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
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