KVK-Tech, Inc.: Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 189

Is my product affected?

Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940

• Brand PHENTERMINE HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

KVK-Tech, Inc. is recalling Phentermine HCL Capsules, USP 15 mg, distributed nationwide in the United States. The recall affects 35,267 bottles in two package sizes: 100-count bottles and 1000-count bottles. Specific lot numbers affected include 12322A, 12323B, 12324A (expiring September 2017), 12455A (expiring December 2017), 12323A (expiring September 2017), and 12456A (expiring December 2017).

The recall was initiated because stability testing at 30 months under room temperature conditions revealed out-of-specification results for individual unknown impurities in retained samples, indicating failed impurities and degradation specifications. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.

Details from the source

Reason for recall: Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test. Distribution: Nationwide in the United States Quantity: 35,267 bottles Lot/code info: Lot # a):12322A, 12323B, 12324A, Exp. Sep 2017; 12455A, Exp. Dec 2017; b) 12323A, Exp. Sep 2017; 12456A, Exp. Dec 2017

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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