Syntex Ireland, Ltd. · 66-66 · IRELAND
For Syntex Ireland, Ltd., import alert is 66-66; country is IRELAND; import alert name is "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122"; product is Ketorolac Tromethamine; product code is 62 G - S 94 Ketorolac Tromethamine (Anti-Inflammatory), Active Pharm Ingred/Chems for Further Manuf; date published is 09/30/2009; address is Clarecastle (Ennis), County , Clare, IRELAND, verified against its source on 2026-09-30.
- Firm
- Syntex Ireland, Ltd. verified
- Import alert
- 66-66
- Import alert name
- "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122"
- Country
- IRELAND verified
- Address
- Clarecastle (Ennis), County , Clare, IRELAND verified
- Date published
- 09/30/2009 verified
- Product code
- 62 G - S 94 Ketorolac Tromethamine (Anti-Inflammatory), Active Pharm Ingred/Chems for Further Manuf verified
- Product
- Ketorolac Tromethamine verified
- FDA notes
- 11/2/2000 verified
What the source says
Syntex Ireland, Ltd. Date Published : 09/30/2009 Clarecastle (Ennis), County , Clare, IRELAND
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
62 G - S 94 Ketorolac Tromethamine (Anti-Inflammatory), Active Pharm Ingred/Chems for Further Manuf Date Published: 03/29/2019 Desc: Ketorolac Tromethamine Notes: 11/2/2000
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_202.html