PlainRecalls
FDA Drug Low Class III Terminated

Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940

Reported: August 30, 2017 Initiated: August 11, 2017 #D-1118-2017

Product Description

Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940

Reason for Recall

Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .

Details

Units Affected
3440 bottles
Distribution
Nationwide.
Location
Oklahoma City, OK

Frequently Asked Questions

What product was recalled?
Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940. Recalled by PD-Rx Pharmaceuticals, Inc.. Units affected: 3440 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Which agency issued this recall?
This recall was issued by the FDA Drug on August 30, 2017. Severity: Low. Recall number: D-1118-2017.