Why it was recalled
cGMP Deviations
Product description
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
TX
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1591-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 18, 2020
- FDA report date
- Sep 30, 2020
- Quantity
- 43,728 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GRUPO YACANA MEXICO SAS DE CV
Original FDA data
Every field from FDA enforcement report D-1591-2020, exactly as published.
Show all FDA fields
- City
- Guadalupe
- Status
- Terminated
- Country
- Mexico
- Event ID
- 86271
- Address
- Avenida Alfonso Reyes 714
- Address (line 2)
- Fracc. Contry La Silla, Guadalupe
- Code information
- All lots
- Report date
- Sep 30, 2020
- Product type
- Drugs
- Recall number
- D-1591-2020
- Classification
- Class II
- Recalling firm
- GRUPO YACANA MEXICO SAS DE CV
- Product quantity
- 43,728 bottles
- Termination date
- May 17, 2023
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0
- Distribution pattern
- TX
- Recall initiation date
- Aug 18, 2020
- Initial firm notification
- Press Release
- Center classification date
- Sep 22, 2020