Multi-event May 2021 FDA Recall Drug by Dibar Nutricional S De Rl De Cv
This Multi-event Class II drug recall was voluntarily initiated by Dibar Nutricional S De Rl De Cv on May 11, 2021 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0647-2021
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.
05-11-2021
07-07-2021
Unknown quantity
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.
DIBAR NUTRICIONAL S DE RL DE CV
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 USA
03-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# All lots
Recall Number: D-0644-2021
Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
05-11-2021
07-07-2021
Unknown quantity
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
DIBAR NUTRICIONAL S DE RL DE CV
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 USA
03-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# LDHSN050920 T1, LDHSN051020 DESC, LDHSN051020 T2, EXP 05/2022
Recall Number: D-0646-2021
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.
05-11-2021
07-07-2021
Unknown quantity
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.
DIBAR NUTRICIONAL S DE RL DE CV
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 USA
03-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# All lots.
Recall Number: D-0645-2021
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.
05-11-2021
07-07-2021
Unknown quantity
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.
DIBAR NUTRICIONAL S DE RL DE CV
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 USA
03-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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, LLC., Sugar Land, TX 77479, Made in Mexico.
Batch or Lot Expiration Information
Lot# All lots
