Drug 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
D-0231-2022
Product summary
- Event
- Event 88873
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36,786 30-count bottles
- Official record key
drug-enforcement:D-0231-2022
Official wording
Reason: Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Code information: Lot # DNC0814A, DNC0815A, Exp. Date 04/2023
Distribution pattern: Distributed to one distributor who may have further distribute the product nationwide.
Derived failure modes
-
Unknown
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.