Why it was recalled
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Product description
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
Lot numbers, UPCs & expiration codes
Lot #: a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19
Where it was sold
Product was distributed U.S. 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-0249-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 5, 2018
- FDA report date
- Oct 24, 2018
- Quantity
- 5,232 bottles: a) 4,146 bottles; b) 1,086 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerigen Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0249-2019, exactly as published.
Show all FDA fields
- City
- Lyndhurst
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81189
- Address
- 9 Polito Ave Ste 900
- Code information
- Lot #: a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19
- Postal code
- 07071-3410
- Report date
- Oct 24, 2018
- Product type
- Drugs
- Recall number
- D-0249-2019
- Classification
- Class III
- Recalling firm
- Amerigen Pharmaceuticals Inc.
- Product quantity
- 5,232 bottles: a) 4,146 bottles; b) 1,086 bottles
- Termination date
- Sep 30, 2019
- Reason for recall
- Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
- Distribution pattern
- Product was distributed U.S. nationwide.
- Recall initiation date
- Oct 5, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 15, 2018