Temozolomide Capsules recall: Failed Dissolution
Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
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?
a) Lot # 18B005 A and b) Lot # 18B005 B, exp 02/2020
- Product
- Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
- Recalling firm
- Amerigen Pharmaceuticals Inc.
- Quantity
- 3552 bottles
- Distribution
- Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
- Recall date
- January 2, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)