Baclofen 500 mcg/mL Injectable recall: Sterility Concern
Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Why was Baclofen 500 mcg/mL Injectable recalled?
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots
- Product
- Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
- Recalling firm
- THE COMPOUNDING SHOP, INC.
- Quantity
- 1 vial of 22mL
- Distribution
- Florida, California, Minnesota, and Maine
- Recall date
- June 12, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)