Drug & medication recalls

Aidarex Pharmaceuticals LLC recalls Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK…

Recall date
September 5, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1162-2017
FDA classification
Class III
Brand / firm
Aidarex Pharmaceuticals LLC
Sold / distributed
Distributed to the state of CA and NV.

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

Class III means the product violates regulations but is not likely to cause harm.

What 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

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