FDA recall D-1033-2013

Product

NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627

Reason for recall

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-08-23

Report date

2013-09-18

Termination date

2014-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Birmingham, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1033-2013