Multi-event October 2021 FDA Recall Tadalafil by Sun Pharmaceutical Industries Inc
This Multi-event Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on October 25, 2021 for the product Tadalafil. The FDA reported the reason for recall as incorrect product formulation. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0231-2022
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
10-25-2021
11-17-2021
36,786 30-count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to one distributor who may have further distribute the product nationwide.
09-01-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0230-2022
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
10-25-2021
11-17-2021
73,957 30-count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to one distributor who may have further distribute the product nationwide.
09-01-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
