Recalls / Class II

Class IID-1582-2015

Product

Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Affected lot / code info

All lots distributed between November 2014 and May 2015; 05112015@22, 5/10/2016; 10202014@63, 10/20/2015; 10272014@17, 10/27/2015; 11102014@20, 11/10/2015; 12302014@8, 12/30/2015; 08252014@26, 8/25/2015; 08262014@20, 8/26/2015; 09052014@13, 9/5/2015; 01262015@15, 1/26/2016; 01022015@22, 1/2/2016; 02232015@50, 2/23/2016; 04132015@59, 4/12/2016; 04222015@40, 4/21/2016; 05062015@21, 5/5/2016; 06042014@17, 6/4/2015

Why it was recalled

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Recalling firm

Firm

The Compounding Pharmacy of America

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

6216 Highland Place Way Ste 101-A, Knoxville, Tennessee 37919-4068

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2015-06-02

FDA classified

2015-09-15

Posted by FDA

2015-09-23

Terminated

2016-02-10

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1582-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.