D-0489-2018 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
- 4910 g
Product Description
Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g (NDC 58597-8001-5); c)100 g (NDC 58597-8001-6), 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) 083017-1, Exp. 7/22/2022; b) 083017-1, Exp. 7/22/2022; c) 083017-1, Exp. 7/22/2022.