Why it was recalled
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Product description
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
Lot numbers, UPCs & expiration codes
Lot code: M04614, Exp 09/30/2024
Where it was sold
Nationwide. No foreign consignees.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0584-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 18, 2024
- FDA report date
- Jul 10, 2024
- Quantity
- 864 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Original FDA data
Every field from FDA enforcement report D-0584-2024, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 94835
- Address
- 341 Mason Rd
- Code information
- Lot code: M04614, Exp 09/30/2024
- Postal code
- 37086-3606
- Report date
- Jul 10, 2024
- Product type
- Drugs
- Recall number
- D-0584-2024
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Product quantity
- 864 cartons
- Termination date
- Dec 22, 2025
- Reason for recall
- Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide. No foreign consignees.
- Recall initiation date
- Jun 18, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 3, 2024