Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Reported: May 3, 2023 Initiated: March 16, 2023 #D-0553-2023
Product Description
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Reason for Recall
CGMP Deviations
Details
- Recalling Firm
- Northwind Pharmaceuticals LLC
- Units Affected
- a)164 bottles; b) 198 bottles
- Distribution
- Nationwide with the United States
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.. Recalled by Northwind Pharmaceuticals LLC. Units affected: a)164 bottles; b) 198 bottles.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 3, 2023. Severity: Moderate. Recall number: D-0553-2023.
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