Reason: Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Distributed: Distributed to one wholesaler in AL for further distribution in the US.Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Distributed: Products were distributed nationwide in the USA.Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Distributed: Products were distributed nationwide in the USA.Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Distributed: Products were distributed nationwide in the USA.Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Distributed: Products were distributed nationwide in the USA.Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Distributed: Products were distributed nationwide in the USA.Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Distributed: Products were distributed nationwide in the USA.Reason: CGMP Deviations
Distributed: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HIReason: CGMP Deviations
Distributed: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HIReason: CGMP Deviations
Distributed: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI