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
Reported: February 27, 2019 Initiated: February 19, 2019 #D-0516-2019
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
Reason for Recall
Failed dissolution specifications
Details
- Recalling Firm
- Amerigen Pharmaceuticals Inc.
- Units Affected
- 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.
- Location
- Lyndhurst, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amerigen Pharmaceuticals Inc.. Units affected: a) 2,413 bottles b) 3,355 bottles.
Why was this product recalled? ▼
Failed dissolution specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 27, 2019. Severity: Low. Recall number: D-0516-2019.
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