October 2017 FDA Recall Paroxetine by Amerisource Health Services
D-0091-2018 - Presence of Foreign Tablets/Capsules.
This Class II drug recall was voluntarily initiated by Amerisource Health Services on October 24, 2017 for the product Paroxetine. The FDA reported the reason for recall as presence of foreign tablets/capsules.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0091-2018
Presence of Foreign Tablets/Capsules.
10-24-2017
11-29-2017
74 cartons (cartons of 100 individual unit doses)
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.
Amerisource Health Services
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 in the USA
06-19-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01
Batch or Lot Expiration Information
Lot# Lot 172291
