Class III · Low risk Ongoing
Morphine Sulfate Oral Solution 100 mg / 5 mL
Reason Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Morphine Sulfate Immediate Release tablet
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
What was recalled
Morphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00
- Recalling firm
- Physicians Total Care, Inc
- NDC code
- 54868-4973-00
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1386-2012
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Morphine recalls
See all
Class II · Moderate risk Ongoing
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets 30 mg
Reason Failed Impurities/Degradation Specification
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets 15 mg
Reason Failed Impurities/Degradation Specification
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