Temozolomide capsules recall: Failed Dissolution
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.
Why was Temozolomide capsules recalled?
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
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) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19
- Product
- 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.
- Recalling firm
- Amerigen Pharmaceuticals Inc.
- Quantity
- 5,232 bottles: a) 4,146 bottles; b) 1,086 bottles
- Distribution
- Product was distributed U.S. nationwide.
- Recall date
- October 24, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)