Reported Aug 30, 2017 · Terminated
Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count…
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 bottle (NDC 55289-791-07) |
| 2 | 14-count bottle ( NDC 55289-791-14) |
| 3 | 21-count bottle (NDC 55289-791-21) |
| 4 | 30-count bottle (NDC 55289-791-30) |
| 5 | 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940 |
- Lot codes and dates
- Lots
a) H15E22Exp. 8/31/17J15E02Exp. 10/31/17. b) J15A53Exp. 10/31/17D16C78Exp.12/31/17c)J15D54Exp. 10/31/17d)H15B60Exp. 8/31/17e) J15A49Exp. 10/31/17C16A14Exp. 12/31/17
- Lots
- Amount recalled
- 3440 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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