Recalls / Class II
Class IID-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
- Brand name
- Tadalafil
- Generic name
- Tadalafil
- Active ingredient
- Tadalafil
- Route
- Oral
- NDCs
- 16714-074, 16714-075, 16714-076, 16714-077
- FDA application
- ANDA208934
- Affected lot / code info
- Lot # DNC0814A, DNC0815A, Exp. Date 04/2023
Why it was recalled
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- NorthStar RxLLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 36,786 30-count bottles
- Distribution pattern
- Distributed to one distributor who may have further distribute the product nationwide.
Timeline
- Recall initiated
- 2021-10-25
- FDA classified
- 2021-11-12
- Posted by FDA
- 2021-11-17
- Terminated
- 2022-09-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0231-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.