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
Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Lot numbers, UPCs & expiration codes
Lot #: a) 021317-4, Exp. 12/31/2021; b) 021317-2R, 021317-4, Exp. 12/31/2021; 050115-4, Exp. 3/31/2020; 101915-5, Exp. 08/31/2020 c) 050115-3, 050115-4, Exp. 03/31/2020; d) 021317-3R, Exp 12/31/2021; 050115-2, 050115-3, Exp. 03/31/2020; 101915-3, 101915-4,101915-5, Exp. 08/31/2020; e) 021317-2R, Exp. 12/31/2021; 050115-2, exp. 03/31/2020; 101915-1, 101915-2,101915-5, Exp. 08/31/2020; f) 021317-1R, 021317-2R,021317-3R, Exp. 12/31/2021; 050115-1, 050115-2, Exp. 03/31/2020; 101915-1, 101915-2, Exp. 08/31/2020.
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-0519-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 9, 2018
- FDA report date
- Feb 28, 2018
- Quantity
- 307500 g
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Pharmaceutical Ingredients LLC
Original FDA data
Every field from FDA enforcement report D-0519-2018, 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) 021317-4, Exp. 12/31/2021; b) 021317-2R, 021317-4, Exp. 12/31/2021; 050115-4, Exp. 3/31/2020; 101915-5, Exp. 08/31/2020 c) 050115-3, 050115-4, Exp. 03/31/2020; d) 021317-3R, Exp 12/31/2021; 050115-2, 050115-3, Exp. 03/31/2020; 101915-3, 101915-4,101915-5, Exp. 08/31/2020; e) 021317-2R, Exp. 12/31/2021; 050115-2, exp. 03/31/2020; 101915-1, 101915-2,101915-5, Exp. 08/31/2020; f) 021317-1R, 021317-2R,021317-3R, Exp. 12/31/2021; 050115-1, 050115-2, Exp. 03/31/2020; 101915-1, 101915-2, Exp. 08/31/2020.
- Postal code
- 48327-1665
- Report date
- Feb 28, 2018
- Product type
- Drugs
- Recall number
- D-0519-2018
- Classification
- Class II
- Recalling firm
- American Pharmaceutical Ingredients LLC
- Product quantity
- 307500 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
- Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), 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