Multi-event May 2020 FDA Recall Drug by Aurobindo Pharma Usa Inc.

This Multi-event Class III drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on May 26, 2020 for the product Drug. The FDA reported the reason for recall as failed impurities/ degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1314-2020 TERMINATED D-1315-2020 TERMINATED

Recall Number: D-1314-2020

Reason for Recall
Failed Impurities/ Degradation Specifications
Initiated
05-26-2020
Reported
06-24-2020
Quantity
13322 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85756
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.
Aurobindo Pharma USA Inc.
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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-10-2023
Product Description About Product Description
Full technical description of the product.
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30

Batch or Lot Expiration Information

Lot# : 561180046A1, Exp 8/2020

Recall Number: D-1315-2020

Reason for Recall
Failed Impurities/ Degradation Specifications
Initiated
05-26-2020
Reported
06-24-2020
Quantity
7547 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85756
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.
Aurobindo Pharma USA Inc.
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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-10-2023
Product Description About Product Description
Full technical description of the product.
Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30

Batch or Lot Expiration Information

Lot# : 563180012A1, Exp 8/2020