FDA Drug recall D-0529-2018
Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4)
- FDA Drug
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4) by American Pharmaceutical Ingredients, citing CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0529-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-09 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Pharmaceutical Ingredients |
| Distribution | US |
Product
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
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Identifiers
| code_info | Lot #: a) UT2140602-1132014, Exp. 05/31/2019; b) UT2140602-1142014, UT2140602-4222015, Exp. 05/31/2019; UT2140602-10292…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0529-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.