Recalls / Class II
Class IID-1320-2014
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
- Affected lot / code info
- Lot #: 556273, Exp 9/25/16; 556219, Exp 8/2/16, or any other lot distributed by Flawless Beauty.
Why it was recalled
Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.
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-1320-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.