Class II
Terminated
PARABEN WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
This recall has been terminated (originally issued September 18, 2013).
- Recall Initiated
- July 26, 2013
- Posted
- September 18, 2013
- Recall Number
- D-987-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Southfield, MI, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Distribution
USA nationwide
Lot / Code Info
04012013@21, 07252013@15
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