Flawless Beauty Recalls Vitamin C Injection Sold Without FDA Approval
Flawless Beauty LLC is recalling Vitamin C Injection ampoules marketed without an approved NDA/ANDA. The product is sold over the counter with labeling indicating disease treatment.
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, as it involves a product marketed without approval for disease treatment.
Plain-English summary
Flawless Beauty LLC is recalling Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box. The product is manufactured by TP Drug Laboratories (1969) Co., Ltd. in Thailand. The recall is due to the product being marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The source text indicates that this parenteral product is sold over the counter, and its labeling indicates it is to be used for the treatment of disease. The recall covers Lot #556273 (Exp 9/25/16), Lot #556219 (Exp 8/2/16), or any other lot distributed by Flawless Beauty. The distribution pattern is listed as nationwide.
Consumers should stop using the product and contact Flawless Beauty LLC for further instructions. The FDA has classified this recall as Class II.
The recalled product
- Product
- Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533
- Manufacturer
- Flawless Beauty LLC
- Category
- Drug — Injection
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 (5)
- Lot #: 556273
- Exp 9/25/16
- 556219
- Exp 8/2/16
- or any other lot distributed by Flawless Beauty.
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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