Drug recall
Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S., Chemical Product for Medicines Preparation, Made in…
FDA recall event 69243 · Class II · Gyma Laboratories Of Amer,Inc
Key facts
| Event ID | 69243 |
|---|---|
| Recall numbers | D-0021-2015, D-0022-2015, D-0023-2015, D-0024-2015 |
| Recalling firm | Gyma Laboratories Of Amer,Inc |
| Product type | Drugs |
| Products | Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01, Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002, Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084, Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 9, 2014 |
| Report date | Oct 22, 2014 |
| Termination date | Jun 4, 2018 |
| City | Westbury |
| State | NY |
| Country | United States |
| FEI number | 2411063 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: