Lyndhurst, NJ, United States
Amerigen Pharmaceuticals Inc. recalls
3 recalls recorded since 2018, most recently on 19 February 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 19 February 2019
- Terminated
- 17 December 2019
- Reason
- Failed dissolution specifications
- Distribution
- Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0516-2019
- 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, L
Terminated Class III Drugs
- Recall started
- 20 December 2018
- Terminated
- 17 December 2019
- Reason
- Failed Dissolution Specifications
- Distribution
- Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0345-2019, D-0344-2019
- Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
- 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, Lyndhu
Terminated Class III Drugs
- Recall started
- 5 October 2018
- Terminated
- 30 September 2019
- Reason
- Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
- Distribution
- Product was distributed U.S. nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0249-2019
- 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,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.