Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals...

FDA Drug Recall #D-1162-2017 — Class III — September 5, 2017

Recall Summary

Recall Number D-1162-2017
Classification Class III — Low risk
Date Initiated September 5, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Aidarex Pharmaceuticals LLC
Location Corona, CA
Product Type Drugs
Quantity 35 bottles

Product Description

Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30

Reason for Recall

Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test

Distribution Pattern

Distributed to the state of CA and NV.

Lot / Code Information

Batch 47262-2, 47262-3, exp 8/31/2017; 47262-4, exp 12/30/17, 47262-5, 47262-6, 47262-7, exp 12/31/17

Other Recalls from Aidarex Pharmaceuticals LLC

Recall # Classification Product Date
D-0992-2018 Class III Enalapril Maleate, USP 5MG, 30-count bottle, RX... Jun 27, 2018
D-0990-2018 Class III Enalapril Maleate, USP 2.5MG, 90-count bottle, ... Jun 27, 2018
D-0991-2018 Class III Enalapril Maleate, USP 5MG, 90-count bottle, RX... Jun 27, 2018
D-0810-2018 Class III Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 Apr 10, 2018
D-0053-2018 Class III ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count b... Sep 5, 2017

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.