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
ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX 77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR 00910, 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-0646-2021
- 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-0646-2021, 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-0646-2021
- 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
- ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX 77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR 00910, 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