buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 cou...

FDA Drug Recall #D-1345-2015 — Class III — July 17, 2015

Recall Summary

Recall Number D-1345-2015
Classification Class III — Low risk
Date Initiated July 17, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Sun Pharma Global Fze
Location Sharm
Product Type Drugs
Quantity 35,235 bottles

Product Description

buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86

Reason for Recall

Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.

Distribution Pattern

Nationwide and Puerto Rico

Lot / Code Information

Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015

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-0386-2015 Class II Levetiracetam, extended release tablets, 750 mg... Jan 21, 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.