Key Takeaway

Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 by Auro Pharmacies, Inc. was recalled on August 21, 2018. The hazard: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

FDA Drug Class II Terminated

Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

Recalled: August 21, 2018 ~91 vials units affected D-1158-2018

Description

Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

Drugs

Company Information

Auro Pharmacies, Inc.

La Habra, CA, United States

View all 12 recalls by Auro Pharmacies, Inc. →

Distribution

Nationwide in USA

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Frequently Asked Questions

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What remedy is available for this recall?

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