Reported Jan 27, 2016 · Terminated
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC…
PD-Rx Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PD-Rx Pharmaceuticals, Inc. · 727 N Ann Arbor Ave · Oklahoma City, OK · 73127-5822
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | 7-count (NDC 55289-791-07) |
| 2 | 14-count (NDC 55289-791-14) |
| 3 | 28-count (NDC 55289-791-28) |
| 4 | 30-count (NDC 55289-791-30), and |
| 5 | 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840. |
- Lot codes and dates
Lot #: a) H14C80Exp 08/16I14G36Exp 09/16b) H14A86Exp 07/16c) H14C83Exp 08/16K14A21Exp 11/16d) H14F25Exp 08/16e) L14C42Exp 12/16
- Amount recalled
- 1685 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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