FDA Recall D-1386-2012
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 Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00
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-1386-2012- 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