Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bott...
FDA Drug Recall #D-332-2014 — Class II — August 8, 2013
Recall Summary
| Recall Number | D-332-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 8, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Novartis Pharmaceuticals Corp. |
| Location | Suffern, NY |
| Product Type | Drugs |
| Quantity | 174,848 bottles |
Product Description
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9560-89
Reason for Recall
Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Distribution Pattern
Nationwide and Puerto Rico
Lot / Code Information
Product code: 715515; Lot Number: F0012, Exp 10/31/2013; F0013, Exp 02/28/2014; F0014, Exp 03/31/2014
Other Recalls from Novartis Pharmaceuticals Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1174-2023 | Class I | SANDIMMUNE Oral Solution (cyclosporine oral sol... | Sep 8, 2023 |
| D-1309-2019 | Class I | Promacta (eltrombopag) 12.5 mg for Oral Suspens... | May 11, 2019 |
| D-0678-2017 | Class III | Isopto Carpine (pilocarpine hydrochloride optha... | Mar 22, 2017 |
| D-0679-2017 | Class III | Pilocarpine Hydrochloride Ophthalmic Solution 4... | Mar 22, 2017 |
| D-1430-2015 | Class III | Dexmethylphenidate HCl Extended-Release, Capsul... | Jul 28, 2015 |
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.