Drug recall D-1118-2017
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 for recall
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Lots and codes
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.
Recall details
- Recalling firm
- PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK
- Quantity
- 3440 bottles
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 11, 2017
- Terminated
- January 29, 2020
Related products
- Phentermine Hydrochloride – drug information
- NDC 55289-791 Phentermine Hydrochloride · Phentermine Hydrochloride 15 mg/1 · PD-Rx Pharmaceuticals, Inc.