Reported Jan 1, 2014 · Terminated

Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Drugs LTD, Pondicherry, INDIA.…

Physicians Total Care, 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: Physicians Total Care, Inc. · 12515 E 55th St Ste 100 · Tulsa, OK · 74146-6234

Is this the product you have?

  • Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only
  • Mfd byShasun Chemicals Drugs LTD, Pondicherry, INDIA
  • Repacked and Distributed byPhysicians Total Care, Inc., Tulsa, OK 74146. 90
  • count bottle
    • NDC: 54868-0816-8
    • 60
  • count bottle
    • NDC: 54868-0816-4
    • 30
  • count bottleNDC: 54686-0816-3
Lot codes and dates
  • NDC 54868-0816-8
  • LOT
    • 6REE
    • EXP. 8/14
    • NDC 54868-0816-4
  • LOT
    • 6RED
    • EXP. 8/14
    • NDC 54868-0816-3
  • LOT
    • 6REB
    • EXP. 8/14
Amount recalled
3,000 tablets

Where it was sold

Why it was recalled

Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.

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 Mar 2, 2016 · Data as of Sep 19, 6:33 PM UTC

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