Drug product
Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00
D-1385-2012
Product summary
- Event
- Event 61233
- Status
- Terminated
- Classification
- Class I
- Quantity
- 540 tablets (9 containers of 60 tablets each)
- Official record key
drug-enforcement:D-1385-2012
Official wording
Reason: Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Code information: PTC Drug Number: 4033. PTC Batch Number: 65IT. Batch Date: 10/13/2010. Expiration Date: 11/30/2011. NDC: 54868-4033-00
Distribution pattern: FL
Derived failure modes
-
Labeling or packaging
Labeling: Label mix-up