Why it was recalled
CGMP Deviations
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.
Lot numbers, UPCs & expiration codes
a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023; F113892202, Exp. Date 11/30/2023; F113892203, Exp. Date 12/31/2023
Where it was sold
Nationwide with the United States
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-0553-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 16, 2023
- FDA report date
- May 3, 2023
- Quantity
- a)164 bottles; b) 198 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Northwind Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-0553-2023, exactly as published.
Show all FDA fields
- City
- Indianapolis
- State
- IN
- Status
- Ongoing
- Country
- United States
- Event ID
- 91944
- Address
- 4838 Fletcher Ave Ste 1000
- Code information
- a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023; F113892202, Exp. Date 11/30/2023; F113892203, Exp. Date 12/31/2023
- Postal code
- 46203-1642
- Report date
- May 3, 2023
- Product type
- Drugs
- Recall number
- D-0553-2023
- Classification
- Class II
- Recalling firm
- Northwind Pharmaceuticals LLC
- Product quantity
- a)164 bottles; b) 198 bottles
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide with the United States
- Recall initiation date
- Mar 16, 2023
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 26, 2023