75%Confidence
0Views
FDASource
2026-03-29Date
Summary
Harvard Drug Group's packaging defect for Midodrine tablets represents a potential patient safety risk due to inadequate sealing, which could compromise drug stability and efficacy. This packaging issue may indicate problems in the packaging process that could affect other products from the same facility.
Actionable: Inspect all blister-packed medications from this manufacturer and consider additional packaging integrity testing.
AI Confidence: 75%
Data Points
firmThe Harvard Drug Group LLC
classificationClass II
statusOngoing
distributionNationwide US.
productMidodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapol
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