Why it was 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.
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.
Lot numbers, UPCs & expiration codes
Lot #: a) 5NON, Exp 04/13; 5YUN, Exp 09/13; b) 5KBJ, Exp 02/13; 5LVX, Exp 04/13
Where it was sold
NC and KY
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1379-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 19, 2011
- FDA report date
- Jun 20, 2012
- Quantity
- a) 4 bottles; b) 2 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Physicians Total Care, Inc.
Original FDA data
Every field from FDA enforcement report D-1379-2012, exactly as published.
Show all FDA fields
- City
- Tulsa
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 62135
- Address
- 12515 E 55th St Ste 100
- Code information
- Lot #: a) 5NON, Exp 04/13; 5YUN, Exp 09/13; b) 5KBJ, Exp 02/13; 5LVX, Exp 04/13
- Postal code
- 74146-6234
- Report date
- Jun 20, 2012
- Product type
- Drugs
- Recall number
- D-1379-2012
- Classification
- Class II
- Recalling firm
- Physicians Total Care, Inc.
- Product quantity
- a) 4 bottles; b) 2 bottles
- Termination date
- Feb 22, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- NC and KY
- Recall initiation date
- Sep 19, 2011
- Initial firm notification
- FAX
- Center classification date
- Jun 14, 2012