D-0287-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 5, 2018
- Initiation Date
- November 14, 2018
- Termination Date
- March 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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