Indomethacin Capsule
FDA Recall NDC 31722-542
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 Indomethacin (NDC 31722-542). A significant event, classified as Class II, was initiated on Jul 18, 2018 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules."
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 II Terminated
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Jul 18, 2018
Aug 08, 2018
18,288 bottles
Recall Profile & Regulatory Data
Event ID
80589
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hetero Labs, Ltd. - Unit III
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 15, 2021
Product Description
Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.
Batch or Lot Expiration Information
Lot# : E180315, Exp 12/19
Affected Packages Involved in this Recall
31722-542-30Product
31722-542-01Product
31722-542-05Product
31722-542-10Product
31722-543-30Product
31722-543-01Product
31722-543-05Product
31722-543-10Product
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.
