Sodium EDTA 150 mg/mL Injectable recall: Sterility Concern
Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Why was Sodium EDTA 150 mg/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
- Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
- Recalling firm
- THE COMPOUNDING SHOP, INC.
- Quantity
- 43 vials of 250mL each
- Distribution
- Florida, California, Minnesota, and Maine
- Recall date
- June 12, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)