D-0531-2018 Class II Terminated
FDA drug recall D-0531-2018 was initiated by American Pharmaceutical Ingredients LLC on Feb 9, 2018 and is designated Class II. 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. The recall status is terminated (terminated Dec 2, 2019). Affected quantity: 25000 g.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 28, 2018
- Initiation Date
- Feb 9, 2018
- Termination Date
- Dec 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25000 g
Product Description
Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), 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) 071316-1, Exp. 05/27/2019; b) 071316-1, Exp. 05/27/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0531-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026