Drug 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
D-0562-2016
Product summary
- Event
- Event 72797
- Status
- Terminated
- Classification
- Class III
- Quantity
- (a) 2 containers, (b) 32 containers, (c) 48 containers
- Official record key
drug-enforcement:D-0562-2016
Official wording
Reason: Subpotent Drug
Code information: Lot# F11641, Exp 9/17/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent