Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Missing Label
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30
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.
Reason Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason Failed Dissolution Specifications
Reason Failed Impurities/Degradation Specification
Reason Failed Impurities/Degradation Specification
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