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
Reported: November 17, 2021 Initiated: October 25, 2021 #D-0231-2022
Product Description
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.
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 36,786 30-count bottles
- Distribution
- Distributed to one distributor who may have further distribute the product nationwide.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 36,786 30-count bottles.
Why was this product recalled? ▼
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 17, 2021. Severity: Moderate. Recall number: D-0231-2022.
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