D-0230-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 17, 2021
- Initiation Date
- October 25, 2021
- Termination Date
- September 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73,957 30-count bottles
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
Reason for Recall
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Distribution Pattern
Distributed to one distributor who may have further distribute the product nationwide.
Code Information
Lot # DNC1127A, exp. date 05/2023