D-0287-2019 Class II Terminated
FDA drug recall D-0287-2019 was initiated by Ascend Laboratories LLC on Nov 14, 2018 and is designated Class II. Reason for recall: Presence of Foreign Substance; metal shard found in tablet The recall status is terminated (terminated Mar 30, 2020).
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 5, 2018
- Initiation Date
- Nov 14, 2018
- Termination Date
- Mar 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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
Reason for Recall
Presence of Foreign Substance; metal shard found in tablet
Distribution Pattern
Nationwide
Code Information
Lot 7143908, exp Nov 2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0287-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026