Reference Source

Syntex Ireland, Ltd. · 66-66 · IRELAND

For Syntex Ireland, Ltd. · 66-66 · IRELAND, import alert is 66-66; 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"; country is IRELAND; 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Syntex Ireland, Ltd. Date Published : 09/30/2009 Clarecastle (Ennis), County , Clare, IRELAND 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

accessdata.fda.gov, retrieved 2026-09-15

Source

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