drugs Class II Updated 2013-09-18

Wellness Pharmacy, Inc. recalls NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot# 130621@28, Use by: 10/19/2013
View official government recall

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