Recalls / Class I
Class ID-1385-2012
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- PTC Drug Number: 4033. PTC Batch Number: 65IT. Batch Date: 10/13/2010. Expiration Date: 11/30/2011. NDC: 54868-4033-00
Why it was recalled
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Recalling firm
- Firm
- Physicians Total Care, Inc
- Notification channel
- FAX
- Type
- Voluntary: Firm initiated
- Address
- 12515 E 55th St Ste 100, N/A, Tulsa, Oklahoma 74146-6234
Distribution
- Quantity
- 540 tablets (9 containers of 60 tablets each)
- Distribution pattern
- FL
Timeline
- Recall initiated
- 2010-11-10
- FDA classified
- 2012-06-18
- Posted by FDA
- 2012-06-27
- Terminated
- 2012-07-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1385-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.