Recalls / Class III
Class IIID-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
- Brand name
- Phentermine Hydrochloride
- Generic name
- Phentermine Hydrochloride
- Active ingredient
- Phentermine Hydrochloride
- Route
- Oral
- NDC
- 55289-791
- FDA application
- ANDA040886
- Affected 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.
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 .
Recalling firm
- Firm
- PD-Rx Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 727 N Ann Arbor Ave, Oklahoma City, Oklahoma 73127-5822
Distribution
- Quantity
- 3440 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2017-08-11
- FDA classified
- 2017-08-23
- Posted by FDA
- 2017-08-30
- Terminated
- 2020-01-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1118-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.