Recalls / Class I

Class ID-1263-2014

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

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

Affected lot / code info: 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. NDC 38779-2673-1, NDC 38779-2673-2, and NDC 38779-2673-6.

Why it was recalled

Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.

Recalling firm

Firm: Medisca Inc.
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: 8300 Esters Blvd Ste 940, Irving, Texas 75063-2272

Distribution

Quantity: 296 units
Distribution pattern: Nationwide

Timeline

Recall initiated: 2013-10-21
FDA classified: 2014-04-25
Posted by FDA: 2014-05-07
Terminated: 2016-11-16
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1263-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.