# Pliva - Kalinovica · 66-66 · CROATIA — FDA import alert red lists: firms subject to detention without physical examination

For Pliva - Kalinovica · 66-66 · CROATIA, 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 CROATIA; product is Atovaquone; product code is 62 L - S 44 Atovaquone (Anti-Protozoal, A-Leishmanial, Anti-Malarial), Active Pharm Ingred/Chems for Further Manuf; date published is 09/30/2009; address is Svetonedjeljska 2 , Sveta Nedelja, Zagrebacka CROATIA, verified against its source on 2026-09-16.

- **Firm:** Pliva - Kalinovica _(verified: appears in the quote below)_
- **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:** CROATIA _(verified: appears in the quote below)_
- **Address:** Svetonedjeljska 2 , Sveta Nedelja, Zagrebacka CROATIA _(verified: appears in the quote below)_
- **Date published:** 09/30/2009 _(verified: appears in the quote below)_
- **Product code:** 62 L - S 44 Atovaquone (Anti-Protozoal, A-Leishmanial, Anti-Malarial), Active Pharm Ingred/Chems for Further Manuf _(verified: appears in the quote below)_
- **Product:** Atovaquone _(verified: appears in the quote below)_
- **FDA notes:** 11/2/2000 _(verified: appears in the quote below)_

## What the source says

> Pliva - Kalinovica Date Published : 09/30/2009 Svetonedjeljska 2 , Sveta Nedelja, Zagrebacka CROATIA 62 L - S 44 Atovaquone (Anti-Protozoal, A-Leishmanial, Anti-Malarial), Active Pharm Ingred/Chems for Further Manuf Date Published: 04/03/2019 Desc: Atovaquone Notes: 11/2/2000

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_202.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).