D-0193-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 17, 2018
- Initiation Date
- November 16, 2017
- Termination Date
- May 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,000 tablets
Product Description
Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Distribution Pattern
Nationwide in the USA, Bermuda, and New Zealand
Code Information
Lot: 07112017@32 BUD: 1/7/2018