Minocycline Hydrochloride Tablet, Film Coated, Extended Release
FDA Recall NDC 67877-577
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 Minocycline Hydrochloride (NDC 67877-577). A significant event, classified as Class III, was initiated on Jan 22, 2020 by Ascend Laboratories, Llc. The reported reason for this action was: "Failed Dissolution Specifications: low out of specification results for dissolution testing."
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
Class III Terminated
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Jan 22, 2020
Feb 12, 2020
4728 bottles
Recall Profile & Regulatory Data
Event ID
84750
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Oct 27, 2021
Product Description
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
Batch or Lot Expiration Information
Lot# : 19140414, Exp 12/2020
Affected Packages Involved in this Recall
67877-578-14Product
67877-578-30Product
67877-578-01Product
67877-578-05Product
67877-576-14Product
67877-576-30Product
67877-576-01Product
67877-576-05Product
67877-577-14Product
67877-577-30Product
67877-577-01Product
67877-577-05Product
67877-643-14Product
67877-643-30Product
67877-643-01Product
67877-643-05Product
67877-644-14Product
67877-644-30Product
67877-644-01Product
67877-644-05Product
67877-436-14Product
67877-436-30Product
67877-436-01Product
67877-436-05Product
67877-437-14Product
67877-437-30Product
67877-437-01Product
67877-437-05Product
67877-438-14Product
67877-438-30Product
67877-438-01Product
67877-438-05Product
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.
