Esomeprazole Magnesium Capsule, Delayed Release
FDA Recall NDC 63304-735
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Esomeprazole Magnesium (NDC 63304-735). A significant event, classified as Class III, was initiated on Jun 21, 2022 by Sun Pharmaceutical Industries, Inc. The reported reason for this action was: "Superpotent Drug: Out of specification for assay at the 12-month timepoint."
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
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Jun 21, 2022
Oct 05, 2022
8640 bottles
Recall Profile & Regulatory Data
Event ID
90891
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Aug 11, 2023
Product Description
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.
Batch or Lot Expiration Information
Lot# Lot AC14304, Exp 12/2022.
Affected Packages Involved in this Recall
63304-734-90Product
63304-734-30Product
63304-734-10Product
63304-735-90Product
63304-735-30Product
63304-735-10Product
Class III Terminated
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Jun 21, 2022
Oct 05, 2022
5712 bottles
Recall Profile & Regulatory Data
Event ID
90891
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Aug 11, 2023
Product Description
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.
Batch or Lot Expiration Information
Lot# Lot AC14299, Exp 12/2022
Affected Packages Involved in this Recall
63304-734-90Product
63304-734-30Product
63304-734-10Product
63304-735-90Product
63304-735-30Product
63304-735-10Product
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.
