FDAFDA · Food and drugs·Recall number D-0230-2022
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
Published November 17, 2021 · Recall initiated: October 25, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TADALAFIL
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Distributed to one distributor who may have further distribute the product nationwide.
- Lot
- Lot # DNC1127A, exp. date 05/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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