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Recall Observatory FDA recall evidence

Drug product

Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250mL bottle, Roqueplast S.A. de C.V. Cda. Adolfo Manfredi #7 Altizapan de Zaragoza CP 52958 Edo de Mexico UPC 8 52239 00689 2

D-1559-2020

August 04, 2020

Class II

Product summary

Firm
ROQUE PLAST, S.A. DE C.V.
Event
Event 86172
Status
Terminated
Classification
Class II
Quantity
311,038 bottles
Official record key
drug-enforcement:D-1559-2020

Official wording

Reason: CGMP Deviation: Potential contamination with undeclared methanol.

Code information: Lots: 200371-12 Exp. 12/17/2023, 200371OH-05 Exp. 12/17/2023, 170420OH-06 Exp. 04/17/2023, 170420OH-8 Exp. 12/17/2023

Distribution pattern: Distributed Nationwide in the US

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    contamination with undeclared methanol
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation