Recalls / Class II
Class IID-1321-2014
Product
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
- Affected lot / code info
- Lot #: 16U394, Exp 04/16; 16U421, Exp 08/16; 16U423, Exp 09/16
Why it was recalled
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
Recalling firm
- Firm
- Flawless Beauty LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1215 Main St, Asbury Park, New Jersey 07712-5940
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-04-29
- FDA classified
- 2014-05-13
- Posted by FDA
- 2014-05-21
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1321-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.