Class I · High risk Ongoing
Glutathione
Reason Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Ascorbic Acid
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
What was recalled
ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
- Recalling firm
- Oregon Compounding Centers, Inc. dba Creative Compounds
- Origin
- OR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0176-2015
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 Ascorbic recalls
See all
Class II · Moderate risk Ongoing
Ascorbic Acid
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ascorbic Acid
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Ascorbic Acid Inj. Solution
Reason Presence of Particulate Matter: Presence of glass particulates.
Class III · Low risk Terminated
Peg-3350
Reason Defective container: potential for non-sealed pouches which can lead to product leakage.
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