Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Reported: June 12, 2013 Initiated: May 2, 2013 #D-552-2013
Product Description
Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Reason for Recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Details
- Recalling Firm
- THE COMPOUNDING SHOP, INC.
- Units Affected
- 3 vials of 45mL
- Distribution
- Florida, California, Minnesota, and Maine
- Location
- St Petersburg, FL
Frequently Asked Questions
What product was recalled? ▼
Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL. Recalled by THE COMPOUNDING SHOP, INC.. Units affected: 3 vials of 45mL.
Why was this product recalled? ▼
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 12, 2013. Severity: Moderate. Recall number: D-552-2013.
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