PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported June 20, 2012

Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. searle LLC Div Pfizer, New York, NY 10017; Repacked & distributed by: Physicians total Care, Inc., Tulsa, OK 74146.

Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.

Recall #
D-1379-2012
Affected scope
a) 4 bottles; b) 2 bottles
Initiated
September 19, 2011
Compiled from official public sources by the editorial team.
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Physicians Total Care, Inc. recalled Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tabl… - a moderate-severity action.

Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tabl… was recalled by Physicians Total Care, Inc. in June 20, 2012. Reason: Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this prod…. Check the official notice for the remedy. Verify recall #D-1379-2012 with the FDA Drug before acting.

The recall

Physicians Total Care, Inc. issued this moderate-severity FDA Drug recall-Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this prod….

Moderate
severity level
Class II
classification
June 20, 2012
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1379-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-1379-2012) was formally reported on June 20, 2012, with the manufacturer initiating the action on September 19, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Physicians Total Care, Inc. is listed as the recalling firm, operating out of Tulsa, OK. Federal records list the affected scope as a) 4 bottles; b) 2 bottles.

The documented reason for this recall is: Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets. Distribution data in the federal record shows the product reached: NC and KY. Distribution scope 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, 5 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.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,287 drugs & medications recalls on record

-50005001,0001,5002,000 2006201220152018202120242026 263
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.

Severity

Moderate

Affected scope

a) 4 bottles; b) 2 bottles

Related Recalls

6

5 from same agency

Product description

Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. searle LLC Div Pfizer, New York, NY 10017; Repacked & distributed by: Physicians total Care, Inc., Tulsa, OK 74146.

Reason for recall

Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.

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-1379-2012
Date reported June 20, 2012
Date initiated September 19, 2011
Recalling firm Physicians Total Care, Inc.
Firm location Tulsa, OK
Affected scope a) 4 bottles; b) 2 bottles
Distribution NC and KY

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-1379-2012) 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?
Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. searle LLC Div Pfizer, New York, NY 10017; Repacked & distributed by: Physicians total Care, Inc., Tulsa, OK 74146.. Recalled by Physicians Total Care, Inc.. Units affected: a) 4 bottles; b) 2 bottles.
Why was this product recalled?
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 20, 2012. Severity: Moderate. Recall number: D-1379-2012.
Where was the recalled product distributed?
Distribution: NC and KY.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-1379-2012) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported June 20, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.