D-0194-2018 Class II Terminated
FDA drug recall D-0194-2018 was initiated by KRS Global Biotechnology, Inc on November 16, 2017 and is designated Class II. 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. The recall status is terminated (terminated May 11, 2020). Affected quantity: 80 cartridges.
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
- 80 cartridges
Product Description
Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, 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: 10122017@8 BUD: 2/9/2018