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.
Reported: October 24, 2018 Initiated: October 5, 2018 #D-0249-2019
Product Description
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.
Reason for Recall
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Details
- Recalling Firm
- Amerigen Pharmaceuticals Inc.
- Units Affected
- 5,232 bottles: a) 4,146 bottles; b) 1,086 bottles
- Distribution
- Product was distributed U.S. nationwide.
- Location
- Lyndhurst, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Amerigen Pharmaceuticals Inc.. Units affected: 5,232 bottles: a) 4,146 bottles; b) 1,086 bottles.
Why was this product recalled? ▼
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 24, 2018. Severity: Low. Recall number: D-0249-2019.
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