Multi-event May 2018 FDA Recall Drug by Shadow Holdings Dba Bocchi Labs
This Multi-event Class II drug recall was voluntarily initiated by Shadow Holdings Dba Bocchi Labs on May 25, 2018 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-0860-2018
CGMP Deviations: products may be contaminated with bacteria.
05-25-2018
06-20-2018
8,208 tubes
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.
Shadow Holdings DBA Bocchi Labs
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.
Nationwide in the USA
08-13-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6.
Batch or Lot Expiration Information
Lot# All lots
Recall Number: D-0861-2018
CGMP Deviations: products may be contaminated with bacteria.
05-25-2018
06-20-2018
4,932 boxes
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.
Shadow Holdings DBA Bocchi Labs
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.
Nationwide in the USA
08-13-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5% tube, and one Power Shaver per box, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos CA 90703 USA, UPC 7 80707 73114 7.
Batch or Lot Expiration Information
Lot# All lots
Recall Number: D-0858-2018
CGMP Deviations: products may be contaminated with bacteria.
05-25-2018
06-20-2018
12,252 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.
Shadow Holdings DBA Bocchi Labs
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.
Nationwide in the USA
08-13-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.
Batch or Lot Expiration Information
Lot# All lots
Recall Number: D-0859-2018
CGMP Deviations: products may be contaminated with bacteria.
05-25-2018
06-20-2018
15,216 tubes
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.
Shadow Holdings DBA Bocchi Labs
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.
Nationwide in the USA
08-13-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) tube, Distributed by: United Exchange Corp., 17211 Valley View Blvd., Cerritos, CA 90703 USA, UPC 7 80707 73112 3.
Batch or Lot Expiration Information
Lot# All lots
