Multi-event August 2022 FDA Recall Drug by Midlab Incorporated
This Multi-event Class II drug recall was voluntarily initiated by Midlab Incorporated on August 8, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Naionwide within the United States and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1463-2022
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
08-08-2022
08-31-2022
892 gallons and one 55-gallon drum
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.
Midlab Incorporated
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Naionwide within the United States
08-15-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b) 55 U.S. Gallon drums (208 Liters) UPC 0 07 61841 02504 0, Midlab 140 Private Brand Way, Athens, TN 37303
Batch or Lot Expiration Information
Lot# : a) 03292022-1, 05092022-1, 02012022-1, 06172022-1, 12132021-1, 07272022-1, and b) 06252022-1
Recall Number: D-1464-2022
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
08-08-2022
08-31-2022
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.
Midlab Incorporated
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Naionwide within the United States
08-15-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottles, Southern Products & Services, Inc. 2515 Jake Drive Ste B, Cumming, GA 30028
Batch or Lot Expiration Information
Lot# : 06172022-1
