CLASS II Drug recall · Reported 1 Jan 2014 · FDA Enforcement Report
Carisoprodol IV ( Carisoprodol Tablets USP) 350mg recalled
Physicians Total Care is recalling Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, distributed in California, Georgia, Missouri, North Carolina. The recall was initiated on 22 Nov 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-390-2014
- FDA event ID
- 67118
- Recalling firm
- Physicians Total Care, Tulsa, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Nov 2013
- FDA classified
- 26 Dec 2013
- Reported
- 1 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- FAX
- Reason category
- Lead & Heavy Metals
Timeline
| 22 Nov 2013 | Recall initiated by company | |
| 26 Dec 2013 | Classified by FDA | +34 days |
| 1 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repacked and Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 count bottle: NDC: 54868-0816-8, 60 count bottle: NDC: 54868-0816-4, 30 count bottle: NDC: 54686-0816-3.
Where it was distributed
CA, GA, NC, and MO
Questions about this recall
Why was it recalled?
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Which lots are affected?
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;
Where was it sold?
CA, GA, NC, and MO
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Physicians Total Care
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|---|---|---|---|---|---|
| Drug | CLASS II | Cephalexin Monohydrate Capsules,USP, 500 mg recalled | Physicians Total Care | Manufacturing (CGMP) Deviations | GA, MO |
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| Drug | CLASS III | Voltaren 1% Gel, 100 gm tube recalled by Physicians Total Care | Physicians Total Care | Other | Nationwide |
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