Recalls / Class II

Class IID-455-2013

Product

Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration,

Affected lot / code info

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Why it was recalled

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Recalling firm

Firm

Nora Apothecary and Alternative Therapies, Inc.

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

1101 E 86th St, N/A, Indianapolis, Indiana 46240-3729

Distribution

Quantity

128

Distribution pattern

Nationwide

Timeline

Recall initiated

2013-04-22

FDA classified

2013-05-29

Posted by FDA

2013-06-05

Terminated

2014-08-01

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-455-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.