August 2020 FDA Recall Drug by Roque Plast, S.a. De C.v.
D-1559-2020 - CGMP Deviation
This Class II drug recall was voluntarily initiated by Roque Plast, S.a. De C.v. on August 4, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviation. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1559-2020
CGMP Deviation: Potential contamination with undeclared methanol.
08-04-2020
09-09-2020
311,038 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
ROQUE PLAST, S.A. DE C.V.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the US
02-08-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 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
