FDA Recall D-1263-2014
Medisca Inc. · Irving, TX
Class I — life-threatening Terminated 1122 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.
Recall record
- Recall number
D-1263-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2013-10-21
- Classified by FDA Center
- 2014-04-25
- FDA published
- 2014-05-07
- Terminated
- 2016-11-16
- Recalling firm
- Medisca Inc.
- Firm location
- Irving, TX