D-0500-2018 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
- 225300 g
Product Description
Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c) 500g (NDC 58597-8336-7); d) 1000g (NDC 58597-8336-8), 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) 051916-1, Exp. 04/30/2019; 061015-1, Exp. 03/03/2018; 041216-2, Exp. 03/27/2019; b) 051916-1, Exp. 04/30/2019; 052517-1, Exp. 02/28/2022; 061015-1, Exp. 03/03/2018; c) 041216-1, Exp. 03/27/2019; 051916-3, Exp. 04/30/2019; 052517-1, Exp. 02/28/2022; 061015-1, Exp. 03/03/2018; d) 041216-1, 041216-3, Exp. 03/27/2019; 051916-2, 051916-3, 051916-4, Exp. 04/30/2019; 061015-1, Exp. 03/03/2018;