Freedom Pharmaceuticals Recalls Subpotent 5-methyltetrahydrofolate Calcium Drug

Plain-English summary

Freedom Pharmaceuticals Inc is voluntarily recalling specific lots of 5-methyltetrahydrofolate Calcium (L) in 1 gm, 5 gm, and 25 gm containers. The recall was initiated because the drug was found to be subpotent, meaning it did not contain the full amount of the active ingredient as labeled.

The affected product is prescription-only and was distributed nationwide. The specific lot number is F11641, with an expiration date of 9/17/2016. The total quantity involved is 82 containers: 2 of the 1 gm size, 32 of the 5 gm size, and 48 of the 25 gm size. The product was manufactured by Hangzhou Dayangchem Co., Ltd. in China.

The FDA classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the supplier or disposed of according to local regulations.

The recalled product

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, Ch

Manufacturer

Freedom Pharmaceuticals Inc

Category

Drug — Prescription Drug

Hazard

• subpotent-drug

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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