Class II
Terminated
NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627
This recall has been terminated (originally issued September 18, 2013).
- Company
- Wellness Pharmacy, Inc.
- Recall Initiated
- August 23, 2013
- Posted
- September 18, 2013
- Recall Number
- D-1033-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 200 Vials
- Firm Location
- Birmingham, AL, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot# 130621@28, Use by: 10/19/2013
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