Why it was recalled
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Product description
Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10
Lot numbers, UPCs & expiration codes
Lot #: 91357
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-1167-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 3, 2014
- FDA report date
- Mar 26, 2014
- Quantity
- 1,557 Boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- McKesson Packaging Services
Original FDA data
Every field from FDA enforcement report D-1167-2014, exactly as published.
Show all FDA fields
- City
- Concord
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 67747
- Address
- 7101 Weddington Rd NW
- Code information
- Lot #: 91357
- Postal code
- 28027-3412
- Report date
- Mar 26, 2014
- Product type
- Drugs
- Recall number
- D-1167-2014
- Classification
- Class III
- Recalling firm
- McKesson Packaging Services
- Product quantity
- 1,557 Boxes
- Termination date
- Aug 14, 2014
- Reason for recall
- Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 3, 2014
- Initial firm notification
- Letter
- Center classification date
- Mar 18, 2014