FDA Drug recall D-0594-2018
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc by Hetero Labs Unit Iii, 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-0594-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-10 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hetero Labs Unit Iii |
| Distribution | NJ |
Product
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30
Reason
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Identifiers
| ndc | 31722-820-30 |
|---|---|
| ndc | 31722-820-01 |
| ndc | 31722-820-31 |
| ndc | 31722-820-32 |
| ndc | 31722-820-05 |
| ndc | 31722-827-30 |
| ndc | 31722-827-01 |
| ndc | 31722-827-31 |
| ndc | 31722-827-32 |
| ndc | 31722-827-05 |
| ndc | 31722-819-30 |
| ndc | 31722-819-01 |
| ndc | 31722-819-31 |
| ndc | 31722-819-32 |
| ndc | 31722-819-05 |
| ndc | 31722-828-30 |
| ndc | 31722-828-01 |
| ndc | 31722-828-31 |
| ndc | 31722-828-32 |
| ndc | 31722-828-05 |
| ndc | 31722-829-30 |
| ndc | 31722-829-01 |
| ndc | 31722-829-31 |
| ndc | 31722-829-32 |
| ndc | 31722-829-05 |
| ndc | 31722-830-30 |
| ndc | 31722-830-01 |
| ndc | 31722-830-31 |
| ndc | 31722-830-32 |
| ndc | 31722-830-05 |
| code_info | Lot #: ARI17089, ARI17090, Exp. 5/2019 |
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-0594-2018%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.