FDA Drug recall D-0595-2018
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11
- FDA Drug
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11 by American Health Packaging, citing CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0595-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-19 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Health Packaging |
| Distribution | US |
Product
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Reason
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Identifiers
| ndc | 60687-157-11 |
|---|---|
| ndc | 60687-157-21 |
| ndc | 60687-157-94 |
| ndc | 60687-168-11 |
| ndc | 60687-168-01 |
| ndc | 60687-168-65 |
| ndc | 60687-179-11 |
| ndc | 60687-179-01 |
| ndc | 60687-179-65 |
| ndc | 60687-191-11 |
| ndc | 60687-191-21 |
| ndc | 60687-191-94 |
| ndc | 60687-202-11 |
| ndc | 60687-202-21 |
| ndc | 60687-202-94 |
| ndc | 60687-213-11 |
| ndc | 60687-213-21 |
| ndc | 60687-213-94 |
| code_info | Lot #: 174096, Exp 05/31/19 |
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-0595-2018%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.