Multi-event January 2017 FDA Recall Drug by Innovagel

This Multi-event Class III drug recall was voluntarily initiated by Innovagel on January 5, 2017 for the product Drug. The FDA reported the reason for recall as subpotent. The product was distributed in NY only and the recall is currently terminated.

Reported Recall Events

D-0674-2017 TERMINATED D-0675-2017 TERMINATED

Recall Number: D-0674-2017

Reason for Recall
Subpotent
Initiated
01-05-2017
Reported
04-26-2017
Quantity
Approximately 7,920,177 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76933
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
InnovaGel
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NY only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2021
Product Description About Product Description
Full technical description of the product.
Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284

Batch or Lot Expiration Information

Batch# : 1404811, 1409802, 1502817, 1504808, 1509810, 1511802, 1603801, Exp. 12/12/2018.

Recall Number: D-0675-2017

Reason for Recall
Subpotent
Initiated
01-05-2017
Reported
04-26-2017
Quantity
9,992,768 softgels

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76933
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
InnovaGel
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NY only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2021
Product Description About Product Description
Full technical description of the product.
Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0067P, NDC 6897080284

Batch or Lot Expiration Information

Batch# : 1508803,1602801, 1602802, 1604801, 1604802, 1606801, 1606802, 1606803, 1606804, Exp. 08/03/2018.