Flawless Beauty Recalls Sterile Water for Injection Sold Without Approval
Flawless Beauty LLC is recalling Sterile Water for Injection ampoules sold over the counter without an approved NDA or ANDA.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score per the rubric.
Plain-English summary
Flawless Beauty LLC is recalling specific lots of Sterile Water for Injection, 5 mL ampoules, packaged in 50-count boxes. The product was manufactured and distributed by Euro Med Laboratories. The affected lots are 16U394 (Exp 04/16), 16U421 (Exp 08/16), and 16U423 (Exp 09/16).
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The product is sold over the counter, and its labeling indicates it is intended for parenteral injection.
Consumers who possess these specific lots of Sterile Water for Injection should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
- Manufacturer
- Flawless Beauty LLC
- Category
- Drug — Sterile Water
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 16U394
- Exp 04/16
- 16U421
- Exp 08/16
- 16U423
- Exp 09/16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Flawless Beauty LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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