Quetiapine Tablet, Film Coated
FDA Recall NDC 67877-249
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Quetiapine (NDC 67877-249). A significant event, classified as Class II, was initiated on Nov 14, 2018 by Ascend Laboratories, Llc. The reported reason for this action was: "Presence of Foreign Substance; metal shard found in tablet"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
November 2018 Class II Recall: Presence of Foreign Substance; metal shard found in tablet
Recall Number
Class II Terminated
Presence of Foreign Substance; metal shard found in tablet
Nov 14, 2018
Dec 05, 2018
N/A
Recall Profile & Regulatory Data
Event ID
81568
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 30, 2020
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
Batch or Lot Expiration Information
Lot# Lot 7143908, exp Nov 2020
Affected Packages Involved in this Recall
67877-242-01Product
67877-242-10Product
67877-242-38Product
67877-242-33Product
67877-249-01Product
67877-249-10Product
67877-249-38Product
67877-249-33Product
67877-250-01Product
67877-250-38Product
67877-250-33Product
67877-250-10Product
67877-245-01Product
67877-245-38Product
67877-245-33Product
67877-246-01Product
67877-246-38Product
67877-246-33Product
67877-246-10Product
67877-247-60Product
67877-247-38Product
67877-247-33Product
67877-247-10Product
67877-248-01Product
67877-248-38Product
67877-248-33Product
67877-248-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
