D-1263-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 7, 2014
- Initiation Date
- October 21, 2013
- Termination Date
- November 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 296 units
Product 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
Reason for Recall
Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.
Distribution Pattern
Nationwide
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.