Why it was recalled
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Product description
Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA.
Lot numbers, UPCs & expiration codes
Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14
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-1067-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 16, 2013
- FDA report date
- Oct 9, 2013
- Quantity
- 57857 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Osmotica Pharmaceutical Corp
Original FDA data
Every field from FDA enforcement report D-1067-2013, exactly as published.
Show all FDA fields
- City
- Marietta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 66226
- Address
- 895 Sawyer Rd
- Code information
- Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14
- Postal code
- 30062
- Report date
- Oct 9, 2013
- Product type
- Drugs
- Recall number
- D-1067-2013
- Classification
- Class III
- Recalling firm
- Osmotica Pharmaceutical Corp
- Product quantity
- 57857 bottles
- Termination date
- May 9, 2014
- Reason for recall
- Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 16, 2013
- Initial firm notification
- Letter
- Center classification date
- Sep 27, 2013