Why it was recalled
CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
Product description
Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01
Lot numbers, UPCs & expiration codes
Lots: F200829088, F200829095, F200829107, D202728743, D202528742, D202428733, D202728743, D2028753, D202528742, D202428733, D202028689, D201828660, D202428734, E200128784, E200418795, D202428734, D202828689, D201828660, E201628912, E201628913, E201628911, E201528902, E201528903, E201628910, E201628918, E201628914, E201628915, E201628916, E201628917, E202328969, E202428975, E202528981, E202128947, E201728918, E201728919, E201428876, E201828894, E201828920, E201428876, E201128850, E201328859, E200628817, E200828826, E200928840, D202128699, D202428700.
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-1565-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 9, 2020
- FDA report date
- Sep 16, 2020
- Quantity
- 245,500 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Maquiladora Miniara Sa De Cv
Original FDA data
Every field from FDA enforcement report D-1565-2020, exactly as published.
Show all FDA fields
- City
- Coyotepec
- Status
- Terminated
- Country
- Mexico
- Event ID
- 86063
- Address
- Crta. Teoloyucan Huehuetoca Km. 22
- Address (line 2)
- Coyotepec
- Code information
- Lots: F200829088, F200829095, F200829107, D202728743, D202528742, D202428733, D202728743, D2028753, D202528742, D202428733, D202028689, D201828660, D202428734, E200128784, E200418795, D202428734, D202828689, D201828660, E201628912, E201628913, E201628911, E201528902, E201528903, E201628910, E201628918, E201628914, E201628915, E201628916, E201628917, E202328969, E202428975, E202528981, E202128947, E201728918, E201728919, E201428876, E201828894, E201828920, E201428876, E201128850, E201328859, E200628817, E200828826, E200928840, D202128699, D202428700.
- Report date
- Sep 16, 2020
- Product type
- Drugs
- Recall number
- D-1565-2020
- Classification
- Class II
- Recalling firm
- Maquiladora Miniara Sa De Cv
- Product quantity
- 245,500 bottles
- Termination date
- Apr 24, 2024
- Reason for recall
- CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jul 9, 2020
- Initial firm notification
- Press Release
- Center classification date
- Sep 10, 2020