FDA Recall D-1385-2012
Physicians Total Care, Inc · Tulsa, OK
Class I — life-threatening Terminated 622 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Recall record
- Recall number
D-1385-2012- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- FAX
- Distribution
- FL
- Recall initiated
- 2010-11-10
- Classified by FDA Center
- 2012-06-18
- FDA published
- 2012-06-27
- Terminated
- 2012-07-24
- Recalling firm
- Physicians Total Care, Inc
- Firm location
- Tulsa, OK