November 2018 FDA Recall Quetiapine by Ascend Laboratories Llc
D-0287-2019 - Presence of Foreign Substance; metal shard found in tablet
This Class II drug recall was voluntarily initiated by Ascend Laboratories Llc on November 14, 2018 for the product Quetiapine. The FDA reported the reason for recall as presence of foreign substance; metal shard found in tablet. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0287-2019
Presence of Foreign Substance; metal shard found in tablet
11-14-2018
12-05-2018
N/A
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.
Ascend Laboratories LLC
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
03-30-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1
Batch or Lot Expiration Information
Lot# Lot 7143908, exp Nov 2020
