Multi-event November 2021 FDA Recall Drug by Amneal Pharmaceuticals Of New York, Llc

This Multi-event Class II drug recall was voluntarily initiated by Amneal Pharmaceuticals Of New York, Llc on November 4, 2021 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0233-2022 TERMINATED D-0234-2022 TERMINATED

Recall Number: D-0233-2022

Reason for Recall
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Initiated
11-04-2021
Reported
11-24-2021
Quantity
7,766 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88997
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amneal Pharmaceuticals of New York, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-09-2022
Product Description About Product Description
Full technical description of the product.
Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86

Batch or Lot Expiration Information

Lot# : 07040001A, exp. date 02/2022

Recall Number: D-0234-2022

Reason for Recall
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Initiated
11-04-2021
Reported
11-24-2021
Quantity
15,88 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88997
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amneal Pharmaceuticals of New York, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-09-2022
Product Description About Product Description
Full technical description of the product.
Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86

Batch or Lot Expiration Information

Lot# : 07030002A, exp. date 02/2022