D-0497-2018 Class II Terminated
FDA drug recall D-0497-2018 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: 52000 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
- 52000 g
Product Description
Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133-6); d) 1000g (NDC 58597-8133-8), 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) 061515-1, Exp. 04/30/2020; b) 080316-1, Exp. 06/30/2021; 052317C-1, Exp 02/28/2022; 061515-1, Exp. 04/30/2020; c) 061515-1, Exp. 04/30/2020; 080316-1, Exp. 06/30/2021; 091216-1, Exp. 07/31/2021; d) 061515-1, 061515-2, exp. 04/30/2020; 080316-1, Exp. 06/30/2021; 091216-1, Exp. 07/31/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0497-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026