D-0192-2018 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
- 30 droptainers
Product Description
Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, 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: 06262017@31 BUD: 6/26/2018