Class II
Terminated
Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
This recall has been terminated (originally issued June 12, 2013).
- Company
- The Compounding Shop, Inc.
- Recall Initiated
- May 2, 2013
- Posted
- June 12, 2013
- Recall Number
- D-550-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1 vial of 22mL
- Firm Location
- St Petersburg, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Distribution
Florida, California, Minnesota, and Maine
Lot / Code Info
All Lots
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