FDA recall D-0562-2016

Product

5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, China

Reason for recall

Subpotent Drug

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-01-08

Report date

2016-01-13

Termination date

2016-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Broken Arrow, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0562-2016