Clonidine HCL — Class II drug recall D-0024-2015
Terminated recall by Gyma Laboratories Of Amer,Inc, reported 2014-10-22, distributed nationwide. cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured i
| Recall number | D-0024-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gyma Laboratories Of Amer,Inc, Westbury, NY, United States |
| Recall initiated | 2014-07-09 |
| Classified | 2014-10-10 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2018-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 97 kilograms |
| Reason classes | cgmp |
| Lot numbers | 163367, 167219, 167220, 167221 |
| Expiration dates | 2017-03 |
Product
Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0024-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.