FDA Drug recall D-0023-2015
Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01
- FDA Drug
- Class II
- terminated
- Published 2014-10-22
On 2014-10-22 the FDA classified a Class II recall of Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01 by Gyma Laboratories, citing cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Ital….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0023-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-09 |
| Published | 2014-10-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Gyma Laboratories |
| Distribution | US |
Product
Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01
Reason
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Identifiers
| code_info | Lot Numbers: 166247, 166248, Exp 10/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0023-2015%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.