Drug recall D-0231-2022
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
Reason for recall
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Lots and codes
Lot # DNC0814A, DNC0815A, Exp. Date 04/2023
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 36,786 30-count bottles
- Distribution
- Distributed to one distributor who may have further distribute the product nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 25, 2021
- Terminated
- September 1, 2022
Related products
- Tadalafil – drug information
- NDC 16714-077 Tadalafil · Tadalafil 20 mg/1 · NorthStar RxLLC
- NDC 16714-074 Tadalafil · Tadalafil 2.5 mg/1 · NorthStar RxLLC
- NDC 16714-075 Tadalafil · Tadalafil 5 mg/1 · NorthStar RxLLC
- NDC 16714-076 Tadalafil · Tadalafil 10 mg/1 · NorthStar RxLLC