Multi-event March 2018 FDA Recall Drug by Elroselabs Inc.
This Multi-event Class II drug recall was voluntarily initiated by Elroselabs Inc. on March 28, 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-0623-2018
cGMP Deviations
03-28-2018
04-18-2018
Unknown
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.
Elroselabs Inc.
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.
Nationwide.
12-15-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford, FL
Batch or Lot Expiration Information
Lot# All product within expiry
Recall Number: D-0622-2018
cGMP Deviations
03-28-2018
04-18-2018
Unknown
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.
Elroselabs Inc.
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.
Nationwide.
12-15-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc.
Batch or Lot Expiration Information
Lot# All product within expiry
Recall Number: D-0621-2018
cGMP Deviations
03-28-2018
04-18-2018
Unknown
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.
Elroselabs Inc.
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.
Nationwide.
12-15-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 70223-001-06
Batch or Lot Expiration Information
Lot# All product within expiry
