CLASS II Drug recall · Reported 20 Jun 2012 · FDA Enforcement Report
Arthrotec 75 (diclofenac sodium and misoprostol) tablets recalled
Physicians Total Care is recalling Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) tablets per, distributed in Kentucky, North Carolina. The recall was initiated on 19 Sep 2011 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-1379-2012
- FDA event ID
- 62135
- Recalling firm
- Physicians Total Care, Tulsa, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Sep 2011
- FDA classified
- 14 Jun 2012
- Reported
- 20 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- FAX
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 19 Sep 2011 | Recall initiated by company | |
| 14 Jun 2012 | Classified by FDA | +269 days |
| 20 Jun 2012 | 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
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
NC and KY
Questions about this recall
Why was it 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 lots are affected?
Lot #: a) 5NON, Exp 04/13; 5YUN, Exp 09/13; b) 5KBJ, Exp 02/13; 5LVX, Exp 04/13
Where was it sold?
NC and KY
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Carisoprodol IV ( Carisoprodol Tablets USP) 350mg recalled | Physicians Total Care | Lead & Heavy Metals | 4 states |
| Drug | CLASS II | Belladonna Alkaloids/PB (Belladonna Alkaloids recalled | Physicians Total Care | Packaging Defects | GA |
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