Class II · Moderate risk
Coenzyme Q10 Injection
Lack of Assurance of Sterility
CoEnzyme-Q10 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
CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Drug: Coenzyme
- Recalling firm
- Auro Pharmacies, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1156-2018 · 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 Coenzyme recalls
See all
Class II · Moderate risk
CoEnzymeQ10 25mg/mL
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Coenzyme Q-10
Labeling: Label Mixup; COENZYME Q-10 Capsule, 100 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD30180_13, EXP: 5/9/2014; ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: AD33897_1, EXP: 5/9/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD37056_1, EXP: 5/10/2014; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 576640
Class II · Moderate risk
Coenzyme Q-10
Labeling: Label Mixup; COENZYME Q-10, Capsule, 30 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: W002819, EXP: 6/7/2014.
Other recalls by Auro Pharmacies, Inc.
All 2018 recalls
Class III · Low risk
Biotin 10 mg/mL Injection
Failed pH Specification: product does not meet pH label claim.
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
Folic Acid 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.
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