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
Reported: January 2, 2019 Initiated: December 20, 2018 #D-0344-2019
Product Description
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
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Amerigen Pharmaceuticals Inc.
- Units Affected
- 3552 bottles
- Distribution
- Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
- Location
- Lyndhurst, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amerigen Pharmaceuticals Inc.. Units affected: 3552 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 2, 2019. Severity: Low. Recall number: D-0344-2019.
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