RecallRadar

FDA Drug recall D-1118-2017

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 55289-79…

On 2017-08-30 the FDA classified a Class III recall of 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 55289-79… by Pd Rx Pharmaceuticals, citing failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1118-2017
ClassificationClass III
Statusterminated
Initiated2017-08-11
Published2017-08-30
Last updated2026-09-13 11:51 UTC
CompanyPd Rx Pharmaceuticals
DistributionUS

Product

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

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

Identifiers

ndc55289-791-07
ndc55289-791-14
ndc55289-791-15
ndc55289-791-21
ndc55289-791-28
ndc55289-791-30
ndc55289-791-60
code_info
Lots: a) H15E22, Exp. 8/31/17; J15E02, Exp. 10/31/17. b) J15A53, Exp. 10/31/17; D16C78, Exp.12/31/17; c)J15D54, Exp. 10…Lots: a) H15E22, Exp. 8/31/17; J15E02, Exp. 10/31/17. b) J15A53, Exp. 10/31/17; D16C78, Exp.12/31/17; c)J15D54, Exp. 10/31/17; d)H15B60, Exp. 8/31/17; e) J15A49, Exp. 10/31/17; C16A14, Exp. 12/31/17.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1118-2017%22

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