Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufa...

FDA Drug Recall #D-0631-2018 — Class III — April 6, 2018

Recall Summary

Recall Number D-0631-2018
Classification Class III — Low risk
Date Initiated April 6, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Sandoz Incorporated
Location Broomfield, CO
Product Type Drugs
Quantity 11,680 bottles

Product Description

Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.

Reason for Recall

Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).

Distribution Pattern

Nationwide in the USA and Puerto Rico

Lot / Code Information

Lot #: GW8264, HD3095, Exp 12/18

Other Recalls from Sandoz Incorporated

Recall # Classification Product Date
D-0943-2017 Class III Amitriptyline HCl Tablets, USP 25 mg, Packaged ... Jun 16, 2017
D-0236-2017 Class II Nadolol Tablets, USP, 40mg, packaged in 1000-co... Dec 22, 2016
D-0291-2015 Class III Fluoxetine Capsules USP, 20 mg, 100 count bottl... Dec 5, 2014
D-1509-2014 Class II Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 ... Jul 25, 2014
D-383-2014 Class II Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/... Oct 22, 2013

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

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.