Product: Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
Reason for recall: Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
Recall initiated: 20140429
Status: Completed
Classification: Class II
Recall type: Voluntary: Firm initiated