FDA recall D-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

Reason for recall

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.

Distribution

Nationwide

Key facts

Status

Completed

Initiation date

2014-04-29

Report date

2014-05-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Asbury Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1320-2014