PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported January 1, 2014

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.

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

Recall #
D-390-2014
Affected scope
3,000 tablets
Initiated
November 22, 2013
Verify with FDA Drug →
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Physicians Total Care, Inc. recalled Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Dru… - a moderate-severity action.

Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Dru… was recalled by Physicians Total Care, Inc. in January 1, 2014. Reason: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product w…. Check the official notice for the remedy. Verify recall #D-390-2014 with the FDA Drug before acting.

The recall

Physicians Total Care, Inc. issued this moderate-severity FDA Drug recall-Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product w….

Moderate
severity level
Class II
classification
January 1, 2014
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-390-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 1 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Children & Baby Products recalls over time

Where this recall sits in its category - 3,781 children & baby products recalls on record

0100200300400500600 20052008201120142017202020232026 196
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

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.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-390-2014
Date reported January 1, 2014
Date initiated November 22, 2013
Recalling firm Physicians Total Care, Inc.
Firm location Tulsa, OK
Affected scope 3,000 tablets
Distribution CA, GA, NC, and MO

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-390-2014) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Physicians Total Care, Inc.. Units affected: 3,000 tablets.
Why was this product recalled?
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 1, 2014. Severity: Moderate. Recall number: D-390-2014.
Where was the recalled product distributed?
Distribution: CA, GA, NC, and MO.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

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This recall: FDA Drug, reported January 1, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026