Class II · Moderate risk Ongoing
GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds…
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
COPPER (SULF), 0.4 mg/mL, injectable, 20 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-0184-2015
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 Copper recalls
See all
Class II · Moderate risk Terminated
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials…
Reason Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Class II · Moderate risk Ongoing
BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Completed
Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL…
Reason Lack of assurance of sterility.
Class I · High risk Terminated
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a…
Reason Non-sterility
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