PD-Rx Pharmaceuticals, Inc.: 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 5

Is my product affected?

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 Mf

• Brand PHENTERMINE HYDROCHLORIDE

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

What happened

PD-Rx Pharmaceuticals, Inc. is recalling Phentermine Capsules, 15 mg, distributed nationwide in bottles containing 7, 14, 21, or 30 capsules. The recall affects 3,440 bottles across multiple lots due to failed impurities and degradation specifications, specifically out-of-specification results for individual unknown impurities detected during 30-month room temperature stability testing of retained samples. The affected lots and expiration dates are: 7-count bottles (lots H15E22 expiring 8/31/17 and J15E02 expiring 10/31/17); 14-count bottles (lots J15A53 expiring 10/31/17, D16C78 expiring 12/31/17); 21-count bottles (lot J15D54 expiring 10/31/17); and 30-count bottles (lots H15B60 expiring 8/31/17, J15A49 expiring 10/31/17, and C16A14 expiring 12/31/17).

The recall notice does not specify any remedy or action for affected consumers to take.

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

Hazard

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

Details from the source

Reason for recall: Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test . Distribution: Nationwide. Quantity: 3440 bottles Lot/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. 10/31/17; d)H15B60, Exp. 8/31/17; e) J15A49, Exp. 10/31/17; C16A14, Exp. 12/31/17.

Source

Official record: FDA (Drug enforcement) ↗

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

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All FDA (Drug enforcement) recalls