Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceutic...

FDA Drug Recall #D-1211-2018 — Class III — September 12, 2018

Recall Summary

Recall Number D-1211-2018
Classification Class III — Low risk
Date Initiated September 12, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hetero Labs, Ltd. - Unit III
Location Hyderabad
Product Type Drugs
Quantity 5,424 bottles

Product Description

Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90

Reason for Recall

Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.

Distribution Pattern

Indiana and Louisiana

Lot / Code Information

Lot #: E181370, Exp. 5/2020

Other Recalls from Hetero Labs, Ltd. - Unit III

Recall # Classification Product Date
D-1019-2018 Class II Indomethacin Capsules, USP, 50 mg, 100-count bo... Jul 18, 2018
D-0594-2018 Class II Aripiprazole Tablets, USP, 10 mg, 30-count bott... Jan 10, 2018
D-0223-2018 Class III Simvastatin Tablets, USP, 40 mg, 1000-count bot... Dec 22, 2017
D-0099-2018 Class II Levetiracetam Oral Solution, USP, 100 mg/mL, pa... Oct 12, 2017

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

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.