Midodrine hydrochloride tablets recalled over inadequately sealed blister packaging
The Harvard Drug Group is recalling one lot of Midodrine Hydrochloride Tablets 5 mg because of a defective container with inadequately sealed blister packaging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers low-risk, precautionary recalls: the fault is confined to the blister seal protecting the tablets, and the source describes no hazard, illness or injury.
Plain-English summary
The Harvard Drug Group LLC is recalling Midodrine Hydrochloride Tablets USP, 5 mg, in 50-tablet packs (5 x 10 blister packs), prescription only, packaged and distributed by Major Pharmaceuticals of Indianapolis, Indiana, NDC 0904-6818-06. About 8,892 cartons were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was initiated for a defective container: inadequately sealed blister packaging. The source record does not describe a specific hazard, illness or injury.
Affected product is lot N02640 with an expiry date of 08/2027.
Patients and pharmacies can identify affected product by the NDC, lot number and expiry date above, and may contact The Harvard Drug Group LLC for further information.
The recalled product
- Product
- MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE)
- Brand
- MIDODRINE HYDROCHLORIDE
- Manufacturer
- The Harvard Drug Group LLC
- Category
- Drug — Prescription tablet
- Affected units
- 8,892
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # N02640
- Exp Date: 08/2027
Distribution
Distributed nationwide across the United States.
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