Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Product description
Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Lot numbers, UPCs & expiration codes
Lot #: a) 070717-2, Exp. 05/31/2020; b) 070717-1, Exp. 05/31/2020; c) 070717-1, Exp. 05/31/2020; d) 070717-1, Exp. 05/31/2020.
Where it was sold
Nationwide within USA.
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-0533-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 9, 2018
- FDA report date
- Feb 28, 2018
- Quantity
- 10000 g
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Pharmaceutical Ingredients LLC
Original FDA data
Every field from FDA enforcement report D-0533-2018, exactly as published.
Show all FDA fields
- City
- Waterford
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 79149
- Address
- 6650 Highland Rd Ste 302
- Code information
- Lot #: a) 070717-2, Exp. 05/31/2020; b) 070717-1, Exp. 05/31/2020; c) 070717-1, Exp. 05/31/2020; d) 070717-1, Exp. 05/31/2020.
- Postal code
- 48327-1665
- Report date
- Feb 28, 2018
- Product type
- Drugs
- Recall number
- D-0533-2018
- Classification
- Class II
- Recalling firm
- American Pharmaceutical Ingredients LLC
- Product quantity
- 10000 g
- Termination date
- Dec 2, 2019
- Reason for recall
- CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Distribution pattern
- Nationwide within USA.
- Recall initiation date
- Feb 9, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 22, 2018