Drug 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
D-1320-2014
Product summary
- Event
- Event 68158
- Status
- Completed
- Classification
- Class II
- Quantity
- unknown
- Official record key
drug-enforcement:D-1320-2014
Official wording
Reason: 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.
Code information: Lot #: 556273, Exp 9/25/16; 556219, Exp 8/2/16, or any other lot distributed by Flawless Beauty.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.