Tadalafil Tablet, Film Coated
FDA Recall NDC 16714-075
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 Tadalafil (NDC 16714-075). A significant event, classified as Class II, was initiated on Oct 25, 2021 by Northstar Rxllc. The reported reason for this action was: "Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product."
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
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Oct 25, 2021
Nov 17, 2021
36,786 30-count bottles
Recall Profile & Regulatory Data
Event ID
88873
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to one distributor who may have further distribute the product nationwide.
Termination Date
Sep 01, 2022
Product Description
Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01
Batch or Lot Expiration Information
Lot# DNC0814A, DNC0815A, Exp. Date 04/2023
Affected Packages Involved in this Recall
16714-074-01Product
16714-074-02Product
16714-075-01Product
16714-076-01Product
16714-077-01Product
Class II Terminated
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Oct 25, 2021
Nov 17, 2021
73,957 30-count bottles
Recall Profile & Regulatory Data
Event ID
88873
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to one distributor who may have further distribute the product nationwide.
Termination Date
Sep 01, 2022
Product Description
Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01
Batch or Lot Expiration Information
Lot# DNC1127A, exp. date 05/2023
Affected Packages Involved in this Recall
16714-074-01Product
16714-074-02Product
16714-075-01Product
16714-076-01Product
16714-077-01Product
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.
