Recalls / Class II

Class IID-0536-2018

Product

Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Affected lot / code info

Lot #: a) 070815-2, Exp. 04/24/2018; b) 070815-2, Exp. 04/24/2018; c) 070815-2, Exp. 04/24/2018; 110416-2, Exp. 06/30/2019; d) 110416-1, Exp. 06/30/2019; 070815-1, Exp. 04/24/2018.

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

7255 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-0536-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.