D-0482-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 28, 2018
- Initiation Date
- February 9, 2018
- Termination Date
- December 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13335 g
Product Description
Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC 58597-8210-6; d) 500g (NDC 58597-8210-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Reason for Recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Distribution Pattern
Nationwide within USA.
Code Information
Lot #: a) 062515-2, Exp. 02/28/2019; b) 062515-1, Exp. 02/28/2019; 062515-2, Exp. 02/28/2019; 052317B-2, Exp. 01/31/2021; c) 052317B-1, Exp. 01/31/2021; 052317B-1, Exp. 01/31/2021; 062515-1, exp. 02/28/2019; d) 052317B-1, Exp. 01/31/2021; 062515-3, exp. 02/28/2019.