Why it was recalled
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
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
Lot numbers, UPCs & expiration codes
Lot # DNC1127A, exp. date 05/2023
Where it was sold
Distributed to one distributor who may have further distribute the product nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0230-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 25, 2021
- FDA report date
- Nov 17, 2021
- Quantity
- 73,957 30-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0230-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88873
- Address
- 2 Independence Way
- Code information
- Lot # DNC1127A, exp. date 05/2023
- Postal code
- 08540-6620
- Report date
- Nov 17, 2021
- Product type
- Drugs
- Recall number
- D-0230-2022
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 73,957 30-count bottles
- Termination date
- Sep 1, 2022
- Reason for recall
- Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed to one distributor who may have further distribute the product nationwide.
- Recall initiation date
- Oct 25, 2021
- Initial firm notification
- Letter
- Center classification date
- Nov 12, 2021