Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 5528...

FDA Drug Recall #D-1118-2017 — Class III — August 11, 2017

Recall Summary

Recall Number D-1118-2017
Classification Class III — Low risk
Date Initiated August 11, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm PD-Rx Pharmaceuticals, Inc.
Location Oklahoma City, OK
Product Type Drugs
Quantity 3440 bottles

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

Reason for Recall

Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .

Distribution Pattern

Nationwide.

Lot / 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.

Other Recalls from PD-Rx Pharmaceuticals, Inc.

Recall # Classification Product Date
D-0163-2025 Class II DULoxetine DR USP, 30 mg, 90-count bottle, Rx O... Dec 4, 2024
D-0558-2023 Class II Simvastatin USP, 10 mg, Rx only, Intas Pharm, L... Apr 6, 2023
D-0559-2023 Class II Glimepiride USP, 4 mg, 90 count-bottles, Rx onl... Apr 6, 2023
D-0560-2023 Class II Simvastatin USP 20 mg, Rx only, Intas Pharm. Li... Apr 6, 2023
D-0557-2023 Class II Montelukast Sodium USP, 10 mg, 30 count-bottles... Apr 6, 2023

Frequently Asked Questions

Nitrosamines are probable human carcinogens — they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.