Status
Terminated
Drug Enforcement D-1385-2012
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Classification
Class I
Report Date
June 27, 2012
Termination Date
July 24, 2012
Product Information
- Product description
- Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00
- Product quantity
- 540 tablets (9 containers of 60 tablets each)
- Reason for recall
- Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
- Recall initiation reason
- —
- Initial firm notification
- FAX
- Distribution pattern
- FL
Location & Firm
- Recalling firm
- Physicians Total Care, Inc
- Address
-
12515 E 55th St Ste 100, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1385-2012
- Event ID
- 61233
- Recall initiation date
- November 10, 2010
- Center classification date
- June 18, 2012
- Code info
- PTC Drug Number: 4033. PTC Batch Number: 65IT. Batch Date: 10/13/2010. Expiration Date: 11/30/2011. NDC: 54868-4033-00
- More code info
- —