FDAClass IIISeptember 20, 2017

Phentermine recall: Impurity Out of Spec

Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA…

Why was Phentermine recalled?

Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA…
Recalling firm
Aidarex Pharmaceuticals LLC
Quantity
35 bottles
Distribution
Distributed to the state of CA and NV.
Recall date
September 20, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls