Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
Reported: September 20, 2017 Initiated: September 5, 2017 #D-1162-2017
Product Description
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
Reason for Recall
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Details
- Recalling Firm
- Aidarex Pharmaceuticals LLC
- Units Affected
- 35 bottles
- Distribution
- Distributed to the state of CA and NV.
- Location
- Corona, CA
Frequently Asked Questions
What product was recalled? ▼
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30. Recalled by Aidarex Pharmaceuticals LLC. Units affected: 35 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 20, 2017. Severity: Low. Recall number: D-1162-2017.
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