Drug 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
D-1263-2014
Product summary
- Firm
- Medisca Inc.
- Event
- Event 67114
- Status
- Terminated
- Classification
- Class I
- Quantity
- 296 units
- Official record key
drug-enforcement:D-1263-2014
Official wording
Reason: Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.
Code information: 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.
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Error