Drug 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.
D-0644-2021
Product summary
- Event
- Event 87917
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unknown quantity
- Official record key
drug-enforcement:D-0644-2021
Official wording
Reason: Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
Code information: Lot # LDHSN050920 T1, LDHSN051020 DESC, LDHSN051020 T2, EXP 05/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination