FDAFDA · Food and drugs·Recall number D-1379-2012
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.
Published June 20, 2012 · Recall initiated: September 19, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.
What to do
Voluntary: Firm initiated · FAX
Recall details
- Manufacturer
- Physicians Total Care, Inc.
- Distributor
- NC and KY
- Lot
- Lot #: a) 5NON, Exp 04/13; 5YUN, Exp 09/13; b) 5KBJ, Exp 02/13; 5LVX, Exp 04/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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