Class III · Low risk
Biotin 10 mg/mL Injection
Failed pH Specification: product does not meet pH label claim.
Folic Acid 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.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Folic Acid injectable, 10 mg/ml, 30 ml Multiple 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-1166-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Auro Pharmacies, Inc.
All 2018 recalls
Class II · Moderate risk
Methyl-Cobalamin injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Testosterone Enanthate/Cypionate injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Testosterone Cypionate/Enanthate injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Other sterility / contamination recalls from 2018
All sterility / contamination recalls
Class II · Moderate risk
Folic Acid
Lack of sterility assurance.
Class II · Moderate risk
Zinc Sulfate
Lack of sterility assurance.
Class II · Moderate risk
Glycyrrhizic Acid
Lack of sterility assurance.
Class II · Moderate risk
Dexpanthenol
Lack of sterility assurance.
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