Major Pharmaceuticals Recalls Midodrine Hydrochloride Tablets Over Packaging Defect
The Harvard Drug Group LLC is recalling nearly 9,000 cartons of Midodrine Hydrochloride Tablets due to inadequately sealed blister packaging that could compromise the medication.
What Happened
The Harvard Drug Group LLC has initiated a voluntary recall of Midodrine Hydrochloride Tablets, USP, 5 mg. The recall was prompted by the discovery of defective containers, specifically inadequately sealed blister packaging. This issue has been classified as a Class II recall by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
Which Products Are Affected
The recall affects the following prescription drug distributed nationwide across the United States:
- Product Name: Midodrine Hydrochloride Tablets, USP, 5 mg
- Packaging: 50 Tablets (5 x 10 blister packs) per carton
- Brand: Major Pharmaceuticals
- NDC Number: 0904-6818-06
- Lot Number: N02640
- Expiration Date: 08/2027
- Quantity: 8,892 cartons
What You Should Do
Consumers, pharmacists, and healthcare providers are advised to immediately check their inventory for the affected lot number (N02640). If the product is identified, it should be set aside and not used or distributed. The firm initiated the recall through notification letters. For instructions regarding the return or disposal of the affected product, contact The Harvard Drug Group LLC at their Dublin, Ohio location.
Why This Matters
Inadequately sealed blister packaging can compromise the integrity of prescription medication by exposing it to environmental factors, which may lead to drug degradation or contamination.
Source
Information provided by the FDA under recall number D-0383-2026.
Source: FDA Official Notice