Key Takeaway
Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regula by Medisca Inc. was recalled on October 21, 2013. The hazard: Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.
Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regula
Description
Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc. Irving, TX, 75063, USA NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6. Lot Numbers 101751/A, Exp: 05/16, CAS: 9002-61-3; 101752/A, Exp: 05/16, CAS 9002-61-3; and 101799/A, Exp: 05/16, CAS: 9002-61-3
Hazard / Reason
Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.
Class I: Dangerous or defective product that could cause serious health problems or death.
Class I is the most serious recall classification used by the FDA, indicating a reasonable probability of serious health consequences or death.
Products Affected
Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regula
DrugsDistribution
Nationwide
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.