Recalls / Class II
Class IID-0584-2024
Product
Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614
- Affected lot / code info
- Lot code: M04614, Exp 09/30/2024
Why it was recalled
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Recalling firm
- Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, N/A, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- 864 cartons
- Distribution pattern
- Nationwide. No foreign consignees.
Timeline
- Recall initiated
- 2024-06-18
- FDA classified
- 2024-07-03
- Posted by FDA
- 2024-07-10
- Terminated
- 2025-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0584-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.