Sterile Water for Injection recall: Labeling Error
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
Why was Sterile Water for Injection recalled?
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
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 #: 16U394, Exp 04/16; 16U421, Exp 08/16; 16U423, Exp 09/16
- Product
- Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
- Recalling firm
- Flawless Beauty LLC
- Quantity
- unknown
- Distribution
- Nationwide
- Recall date
- May 21, 2014
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)