Status
Terminated
Drug Enforcement D-1379-2012
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.
Classification
Class II
Report Date
June 20, 2012
Termination Date
February 22, 2013
Product Information
- 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.
- Product quantity
- a) 4 bottles; b) 2 bottles
- 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 initiation reason
- —
- Initial firm notification
- FAX
- Distribution pattern
- NC and KY
Location & Firm
- Recalling firm
- Physicians Total Care, Inc.
- Address
-
12515 E 55th St Ste 100
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1379-2012
- Event ID
- 62135
- Recall initiation date
- September 19, 2011
- Center classification date
- June 14, 2012
- Code info
- Lot #: a) 5NON, Exp 04/13; 5YUN, Exp 09/13; b) 5KBJ, Exp 02/13; 5LVX, Exp 04/13
- More code info
- —