D-0529-2018 Class II Terminated
FDA drug recall D-0529-2018 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: 63975 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
- 63975 g
Product Description
Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); c) 500g (NDC 58597-8032-7); d)1000g (NDC 58597-8032-8), 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) UT2140602-1132014, Exp. 05/31/2019; b) UT2140602-1142014, UT2140602-4222015, Exp. 05/31/2019; UT2140602-10292014, Exp. 05/31/02019; UT2131205UI-1192015, Exp.11/30/2018; UT2140602-10292014, Exp. 05/31/2019; c) UT2140602-10282014, Exp. 05/31/2019; UT2131205UI, Exp. 11/30/2018; UT2140602-4222015, Exp. 5/31/2019; d) UT2140602-10282014, Exp. 05/31/2019; UT2131205UI, UT2131205UI-1192015, Exp. 11/30/2018.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0529-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026