KVK-Tech Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

Plain-English summary

KVK-Tech, Inc. is recalling specific lots of Phentermine Hydrochloride Capsules, USP, 15 mg. The affected products are packaged in 100-count and 1,000-count bottles and are distributed nationwide. The recall involves approximately 9,696 bottles of the 100-count size and 972 bottles of the 1,000-count size.

The recall was initiated because the products failed impurities and degradation specifications. Specifically, out-of-specification results were found for individual unknown and total impurity at the 12th month room temperature stability test station. The affected lot numbers are 11957A (100-count) and 11956A (1,000-count), both with an expiration date of 04/2017.

Consumers and healthcare providers should check their inventory for these specific NDCs and lot numbers. If the products are found, they should be returned to the distributor or disposed of according to local regulations. This is an FDA Class III recall, indicating that the violation is not likely to cause adverse health consequences.

The recalled product

Product

Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA

Manufacturer

KVK-Tech, Inc.

Category

Drug — Prescription Medication

Hazard

• impurity

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls