Edetate Disodium Injection recall: Sterility Concern
Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate Disodium 150/100 mL, Rx only…
Why was Edetate Disodium Injection recalled?
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the 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?
Lot #: a) Edetate Disodium_150/30 mL: 20130201-E, Exp 5/2/2013; b) Edetate Disodium_150/100 mL: 20130124-B, 4/24/2013; 20130213-B, Exp 5/13/2013; 20130213-C, Exp 5/13/2013; 20130401-B, Exp 7/1/2013
- Product
- Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate Disodium 150/100 mL, Rx only…
- Recalling firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Quantity
- 98 vials
- Distribution
- Nationwide
- Recall date
- May 22, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)