The Recall Desk

FDA (Drugs) recall action 87917

DIBAR NUTRICIONAL S DE RL DE CV recalled 4 products on 2021-07-07

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2021-07-07
Critical
0
Units
—

Why these products were 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.

Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.

The agency’s own wording, quoted from the enforcement report.

1–4 of 4

  • SevereFDA (Drugs)··2021-07-07

    ProtectoRx Ethyl Alcohol 70% Hand Sanitizer Recalled for Methanol Contamination

    ProtectoRx hand sanitizer (ethyl alcohol 70%) is being recalled nationwide because some lots were found to contain methanol and all lots were manufactured under the same conditions as the contaminated product.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-07-07

    DiBAR LABS Hand Sanitizer Recalled for Methanol Contamination

    DiBAR LABS Hand Sanitizer (70% ethyl alcohol) in 16 FL OZ and 8 FL OZ bottles is being recalled nationwide because other lots and products made under the same conditions were found to contain methanol.

    Product
    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…
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-07-07

    Advance Hand Sanitizer Recalled for Methanol Contamination

    Dibar Labs is recalling Advance Hand Sanitizer (70% ethyl alcohol, 16 FL OZ) distributed nationwide because it was manufactured under the same conditions as lots found to contain methanol.

    Product
    ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-07-07

    DiBAR LABS Hand Sanitizer Recalled for Methanol Contamination

    DiBAR LABS Hand Sanitizer (ethyl alcohol 70%, 8 FL OZ) is being recalled because FDA testing found three lots contain methanol contamination and have ethanol content below the label claim.

    Product
    DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Imported by Dibar Labs, LLC, Sugar Land, TX 77479, Made in Mexico,77479, NDC 73009-0001-08 UPC 8 53090 00301 3.
    Category
    Distribution
    0 states