CLASS II Drug recall · Reported 22 Oct 2014 · FDA Enforcement Report
Clonidine Base Micronized recalled by Gyma Laboratories Of Amer
Gyma Laboratories Of Amer is recalling Clonidine Base Micronized, distributed nationwide in the US. The recall was initiated on 9 Jul 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0023-2015
- FDA event ID
- 69243
- Recalling firm
- Gyma Laboratories Of Amer, Westbury, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jul 2014
- FDA classified
- 10 Oct 2014
- Reported
- 22 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Blood Pressure Medication
Timeline
| 9 Jul 2014 | Recall initiated by company | |
| 10 Oct 2014 | Classified by FDA | +93 days |
| 22 Oct 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Numbers: 166247, 166248, Exp 10/2016
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 69243| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Propranolol HCl recalled by Gyma Laboratories Of Amer | Gyma Laboratories Of Amer | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Dipyridamole API recalled by Gyma Laboratories Of Amer | Gyma Laboratories Of Amer | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Clonidine HCL recalled by Gyma Laboratories Of Amer | Gyma Laboratories Of Amer | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Gyma Laboratories Of Amer
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clonidine HCL recalled by Gyma Laboratories Of Amer | Gyma Laboratories Of Amer | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Dipyridamole API recalled by Gyma Laboratories Of Amer | Gyma Laboratories Of Amer | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Propranolol HCl recalled by Gyma Laboratories Of Amer | Gyma Laboratories Of Amer | Manufacturing (CGMP) Deviations | Nationwide |