Why it was recalled
Failed dissolution specifications
Product description
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
Lot numbers, UPCs & expiration codes
Lot #: a) 18J043A, Exp 09/30/2020, b) 18J043B, Exp 09/30/2020
Where it was sold
Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
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-0516-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 19, 2019
- FDA report date
- Feb 27, 2019
- Quantity
- a) 2,413 bottles b) 3,355 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerigen Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0516-2019, exactly as published.
Show all FDA fields
- City
- Lyndhurst
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82158
- Address
- 9 Polito Ave Ste 900
- Code information
- Lot #: a) 18J043A, Exp 09/30/2020, b) 18J043B, Exp 09/30/2020
- Postal code
- 07071-3410
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0516-2019
- Classification
- Class III
- Recalling firm
- Amerigen Pharmaceuticals Inc.
- Product quantity
- a) 2,413 bottles b) 3,355 bottles
- Termination date
- Dec 17, 2019
- Reason for recall
- Failed dissolution specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
- Distribution pattern
- Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
- Recall initiation date
- Feb 19, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 20, 2019