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
Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Lot numbers, UPCs & expiration codes
Lot #: a) 052615-2, Exp. 4/30/2020; 020916-1, Exp. 12/31/2020; b) 092115-1, Exp. 8/31/2020; 092115-2, Exp. 8/31/2020; 020916-1, Exp. 12/31/2020; 110315-3, Exp. 9/30/2020; c) 020916-1, Exp. 12/31/2020, 110315-2, Exp. 9/30/2020; d) 020916-1, Exp. 12/31/2020
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-0539-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 9, 2018
- FDA report date
- Feb 28, 2018
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Pharmaceutical Ingredients LLC
Original FDA data
Every field from FDA enforcement report D-0539-2018, 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) 052615-2, Exp. 4/30/2020; 020916-1, Exp. 12/31/2020; b) 092115-1, Exp. 8/31/2020; 092115-2, Exp. 8/31/2020; 020916-1, Exp. 12/31/2020; 110315-3, Exp. 9/30/2020; c) 020916-1, Exp. 12/31/2020, 110315-2, Exp. 9/30/2020; d) 020916-1, Exp. 12/31/2020
- Postal code
- 48327-1665
- Report date
- Feb 28, 2018
- Product type
- Drugs
- Recall number
- D-0539-2018
- Classification
- Class II
- Recalling firm
- American Pharmaceutical Ingredients LLC
- 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
- Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), 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