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Class III: unlikely to cause harmTerminated

Freedom Pharmaceuticals 5-methyltetrahydrofolate Calcium Recall

5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04

Freedom Pharmaceuticals Inc · Broken Arrow, OK

Risk level
Class III
Reported by FDA
Jan 13, 2016
Recall ID
D-0562-2016
Check your lot numberHow we source this data

Summary

Freedom Pharmaceuticals recalled 5-methyltetrahydrofolate Calcium starting Jan 8, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0562-2016 on Jan 13, 2016. Reason: Subpotent Drug. Status: Terminated.

Why it was recalled

Subpotent Drug

Product description

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

Lot numbers, UPCs & expiration codes

Lot# F11641, Exp 9/17/2016

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0562-2016
Classification
Class III
Status
Terminated
Recall initiated
Jan 8, 2015
FDA report date
Jan 13, 2016
Quantity
(a) 2 containers, (b) 32 containers, (c) 48 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Freedom Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-0562-2016, exactly as published.

Show all FDA fields
City
Broken Arrow
State
OK
Status
Terminated
Country
United States
Event ID
72797
Address
801 W New Orleans St
Code information
Lot# F11641, Exp 9/17/2016
Postal code
74011-1844
Report date
Jan 13, 2016
Product type
Drugs
Recall number
D-0562-2016
Classification
Class III
Recalling firm
Freedom Pharmaceuticals Inc
Product quantity
(a) 2 containers, (b) 32 containers, (c) 48 containers
Termination date
Feb 8, 2016
Reason for recall
Subpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide
Recall initiation date
Jan 8, 2015
Initial firm notification
Telephone
Center classification date
Jan 6, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0562-2016, published Jan 13, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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