D-0528-2018 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
- 192000 g
Product Description
Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), 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) b) 032117C-1, Exp. 02/11/2020; 070716-2, Exp. 03/22/2019; 121616-1, Exp. 08/20/2019; 071516-3, Exp. 4/1/2019; c) 032117C-1, Exp. 02/11/2020; 070716-1, Exp. 03/22/2019; 070716-2, Exp. 03/22/2019; 121616-1, Exp. 08/20/2019 d) 032117C-1, Exp. 02/11/2020; 061317-1, Exp. 4/30/2020; 061617-1, Exp. 05/01/2020; 070716-1, 070716-2, Exp. 03/22/2019; 121616-1, Exp. 8/20/2019.