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 .
Product description
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
Lot numbers, UPCs & expiration 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.
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1118-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 11, 2017
- FDA report date
- Aug 30, 2017
- Quantity
- 3440 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1118-2017, exactly as published.
Show all FDA fields
- City
- Oklahoma City
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 77915
- Address
- 727 N Ann Arbor Ave
- Code information
- 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.
- Postal code
- 73127-5822
- Report date
- Aug 30, 2017
- Product type
- Drugs
- Recall number
- D-1118-2017
- Classification
- Class III
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Product quantity
- 3440 bottles
- Termination date
- Jan 29, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Aug 11, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 23, 2017