Recalls / Class II

Class IID-1122-2014

Product

Idoxuridine 0.1% Ophthalmic

Affected lot / code info

All lot numbers within expiry.

Why it was recalled

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Recalling firm

Firm

Natures Pharmacy & Compounding Center

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

752 Biltmore Ave, Asheville, North Carolina 28803-2558

Distribution

Distribution pattern

NC

Timeline

Recall initiated

2013-11-01

FDA classified

2014-03-04

Posted by FDA

2014-03-12

Terminated

2014-04-24

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1122-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.