FDA Drug recall D-0574-2016
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC…
- FDA Drug
- Class III
- terminated
- Published 2016-01-27
On 2016-01-27 the FDA classified a Class III recall of Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC… by Pd Rx Pharmaceuticals, citing failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0574-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-07-21 |
| Published | 2016-01-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pd Rx Pharmaceuticals |
| Distribution | US |
Product
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840.
Reason
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Identifiers
| ndc | 55289-791-07 |
|---|---|
| ndc | 55289-791-14 |
| ndc | 55289-791-15 |
| ndc | 55289-791-21 |
| ndc | 55289-791-28 |
| ndc | 55289-791-30 |
| ndc | 55289-791-60 |
| code_info | Lot #: a) H14C80, Exp 08/16; I14G36, Exp 09/16; b) H14A86, Exp 07/16; c) H14C83, Exp 08/16, K14A21, Exp 11/16; d) H14F25, Exp 08/16; e) L14C42, Exp 12/16. |
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-0574-2016%22
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