Freedom Pharmaceuticals Recalls Subpotent 5-methyltetrahydrofolate Calcium Drug
Freedom Pharmaceuticals is voluntarily recalling specific lots of 5-methyltetrahydrofolate Calcium because the drug was found to be subpotent.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
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…
- Manufacturer
- Freedom Pharmaceuticals Inc
- Category
- Drug — Prescription Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# F11641
- Exp 9/17/2016
Distribution
Distributed nationwide across the United States.
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