Recalls / Class III
Class IIID-1162-2017
Product
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
- Affected lot / code info
- Batch 47262-2, 47262-3, exp 8/31/2017; 47262-4, exp 12/30/17, 47262-5, 47262-6, 47262-7, exp 12/31/17
Why it was recalled
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Recalling firm
- Firm
- Aidarex Pharmaceuticals LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 595 N Smith Ave Ste B, N/A, Corona, California 92880-6920
Distribution
- Quantity
- 35 bottles
- Distribution pattern
- Distributed to the state of CA and NV.
Timeline
- Recall initiated
- 2017-09-05
- FDA classified
- 2017-09-13
- Posted by FDA
- 2017-09-20
- Terminated
- 2019-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1162-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.