Recalls / Class II

Class IID-0528-2018

Product

Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Affected lot / code info

Lot #: a) b) 032117C-1, Exp. 02/11/2020; 070716-2, Exp. 03/22/2019; 121616-1, Exp. 08/20/2019; 071516-3, Exp. 4/1/2019; c) 032117C-1, Exp. 02/11/2020; 070716-1, Exp. 03/22/2019; 070716-2, Exp. 03/22/2019; 121616-1, Exp. 08/20/2019 d) 032117C-1, Exp. 02/11/2020; 061317-1, Exp. 4/30/2020; 061617-1, Exp. 05/01/2020; 070716-1, 070716-2, Exp. 03/22/2019; 121616-1, Exp. 8/20/2019.

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

192000 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-0528-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.