August 2020 FDA Recall Drug by Par Pharmaceutical Inc.
D-1542-2020 - Failed Impurity /Degradation Specifications
This Class II drug recall was voluntarily initiated by Par Pharmaceutical Inc. on August 10, 2020 for the product Drug. The FDA reported the reason for recall as failed impurity /degradation specifications. The product was distributed in Product was distributed to 9 major distributors throughout the United States. and the recall is currently terminated.
Recall Number: D-1542-2020
Failed Impurity /Degradation Specifications
08-10-2020
09-02-2020
11,347 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.
Par Pharmaceutical 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.
Product was distributed to 9 major distributors throughout the United States.
06-07-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Batch or Lot Expiration Information
Lot# 32091002, exp. date May 2021
