Class II · Moderate risk Ongoing
B5 Dexpanthenol for Injection
Reason Lack of Assurance of Sterility
Dexpanthenol injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
What was recalled
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
- Recalling firm
- Auro Pharmacies, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1158-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Dexpanthenol recalls
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Class II · Moderate risk Ongoing
LX Bioboost Plus
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
B-Complex
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
Thiamine/Ribofla/Niacinami/Dexpanth/Pyridox/Hydroxycobal…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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