Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Ph...

FDA Drug Recall #D-0386-2015 — Class II — January 21, 2015

Recall Summary

Recall Number D-0386-2015
Classification Class II — Moderate risk
Date Initiated January 21, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Sun Pharma Global Fze
Location Sharm, N/A
Product Type Drugs
Quantity 3263 bottles

Product Description

Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86

Reason for Recall

Failed Dissolution Specifications: 6 month time point.

Distribution Pattern

Nationwide.

Lot / Code Information

Lot #: JKN0249A Exp 02/2016

Other Recalls from Sun Pharma Global Fze

Recall # Classification Product Date
D-0735-2016 Class II Alendronate Sodium Tablets, USP, 70 mg*, 4-coun... Feb 11, 2016
D-1345-2015 Class III buPROPion Hydrochloride Extended-¿release Table... Jul 17, 2015
D-0394-2015 Class II Ketorolac Tromethamine Ophthalmic Solution, 0.5... Jan 21, 2015

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.