D-0525-2018 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
- 33000 g
Product Description
Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), 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) 071516-3, Exp. 04/01/2019; b) 071516-3, Exp. 4/1/2019; c) 071516-1, 071516-2, Exp. 04/01/2019; d) 071516-1, 071516-3, Exp. 04/01/2019, 032117B-1, Exp. 2/9/2020.