Recalls / Class II

Class IID-0500-2018

Product

Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c) 500g (NDC 58597-8336-7); d) 1000g (NDC 58597-8336-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Affected lot / code info

Lot #: a) 051916-1, Exp. 04/30/2019; 061015-1, Exp. 03/03/2018; 041216-2, Exp. 03/27/2019; b) 051916-1, Exp. 04/30/2019; 052517-1, Exp. 02/28/2022; 061015-1, Exp. 03/03/2018; c) 041216-1, Exp. 03/27/2019; 051916-3, Exp. 04/30/2019; 052517-1, Exp. 02/28/2022; 061015-1, Exp. 03/03/2018; d) 041216-1, 041216-3, Exp. 03/27/2019; 051916-2, 051916-3, 051916-4, Exp. 04/30/2019; 061015-1, Exp. 03/03/2018;

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

225300 g

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-0500-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.