Why it was recalled
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Product description
DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL) bottle, NDC 73009-001-16, UPC 8 53090 00302 0 and b) 8 FL OZ (236.5 mL) bottle, NDC 73009-0001-08, UPC 8 53090 00301 3; Distributed by: S.E.N.D, LLC., Anthony, NM 88021; Imported by: Dibar Labs, LLC., Sugar Land, TX 77479, Made in Mexico.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Distributed Nationwide in the USA
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-0645-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 11, 2021
- FDA report date
- Jul 7, 2021
- Quantity
- Unknown quantity
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- DIBAR NUTRICIONAL S DE RL DE CV
Original FDA data
Every field from FDA enforcement report D-0645-2021, exactly as published.
Show all FDA fields
- City
- Morelia
- Status
- Terminated
- Country
- Mexico
- Event ID
- 87917
- Address
- Sargento Manuel De La Rosa #145
- Address (line 2)
- Col Chapultepec Sur
- Code information
- All lots
- Report date
- Jul 7, 2021
- Product type
- Drugs
- Recall number
- D-0645-2021
- Classification
- Class II
- Recalling firm
- DIBAR NUTRICIONAL S DE RL DE CV
- Product quantity
- Unknown quantity
- Termination date
- Mar 8, 2023
- Reason for recall
- CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL) bottle, NDC 73009-001-16, UPC 8 53090 00302 0 and b) 8 FL OZ (236.5 mL) bottle, NDC 73009-0001-08, UPC 8 53090 00301 3; Distributed by: S.E.N.D, LLC., Anthony, NM 88021; Imported by: Dibar Labs, LLC., Sugar Land, TX 77479, Made in Mexico.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- May 11, 2021
- Initial firm notification
- Press Release
- Center classification date
- Jun 29, 2021