Why it was recalled
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Product description
Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.
Lot numbers, UPCs & expiration codes
Lot # 94983; Exp 10/17
Where it was sold
Nationwide
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-0837-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 25, 2016
- FDA report date
- May 11, 2016
- Quantity
- 21 bottles (910 extended release tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bryant Ranch Prepack Inc.
Original FDA data
Every field from FDA enforcement report D-0837-2016, exactly as published.
Show all FDA fields
- City
- Burbank
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 73683
- Address
- 1919 N Victory Pl
- Code information
- Lot # 94983; Exp 10/17
- Postal code
- 91504-3425
- Report date
- May 11, 2016
- Product type
- Drugs
- Recall number
- D-0837-2016
- Classification
- Class III
- Recalling firm
- Bryant Ranch Prepack Inc.
- Product quantity
- 21 bottles (910 extended release tablets)
- Termination date
- Aug 29, 2016
- Reason for recall
- Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 25, 2016
- Initial firm notification
- Letter
- Center classification date
- May 4, 2016