Recalls / Class I
Class ID-1386-2012
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 Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00
- Affected lot / code info
- PTC Drug Number: 4973. PTC Batch Number: 65J2. Batch Date: 10/13/2010. Expiration Date: 06/30/2012. NDC: 54868-4973-00
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
- 600 tablets (5 containers of 120 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-1386-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.