Recalls / Class II

Class IID-0497-2018

Product

Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133-6); d) 1000g (NDC 58597-8133-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Affected lot / code info

Lot #: a) 061515-1, Exp. 04/30/2020; b) 080316-1, Exp. 06/30/2021; 052317C-1, Exp 02/28/2022; 061515-1, Exp. 04/30/2020; c) 061515-1, Exp. 04/30/2020; 080316-1, Exp. 06/30/2021; 091216-1, Exp. 07/31/2021; d) 061515-1, 061515-2, exp. 04/30/2020; 080316-1, Exp. 06/30/2021; 091216-1, Exp. 07/31/2021

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

52000 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-0497-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.