Reported Jan 27, 2016 · Terminated

Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container),…

Freedom Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Freedom Pharmaceuticals Inc · 801 W New Orleans St · Broken Arrow, OK · 74011-1844

Is this the product you have?

    • Baclofen USP powder
    • packaged in (a) 25gm (4 oz container)
    • (b) 100gm (16 oz container)
    • (c) 500 gm (70 oz container)
    • and (d) 1000 gm (120 oz container
    • Rx only
    • 801 W New Orleans St. Broken Arrow
    • OK 74011
  • NDC
    • (a) 52372-0909-25
    • (b) 52372-0909-01
    • (c) 52372-0909-50
    • (d) 52372-0909-10
Lot codes and dates
    • Lot #: F10918
    • F10918-2
  • Exp
    • 07/24/2016
    • F10867
    • F10867A
  • Exp date03/11/2016
Amount recalled
(a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Substance

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 23, 2016 · Data as of Sep 19, 4:59 PM UTC

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