Temozolomide Capsules recall: Failed Dissolution
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
Why was Temozolomide Capsules recalled?
Failed dissolution specifications
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) 18J043A, Exp 09/30/2020, b) 18J043B, Exp 09/30/2020
- Product
- 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
- Recalling firm
- Amerigen Pharmaceuticals Inc.
- Quantity
- a) 2,413 bottles b) 3,355 bottles
- Distribution
- Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
- Recall date
- February 27, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)