Recalls / Class II

Class IID-0539-2018

Product

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

Affected lot / code info

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

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.

Recalling firm

Firm

American Pharmaceutical Ingredients LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

6650 Highland Rd Ste 302, N/A, Waterford, Michigan 48327-1665

Distribution

Quantity

N/A

Distribution pattern

Nationwide within USA.

Timeline

Recall initiated

2018-02-09

FDA classified

2018-02-22

Posted by FDA

2018-02-28

Terminated

2019-12-02

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0539-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.