Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-013...

FDA Drug Recall #D-1287-2015 — Class III — June 30, 2015

Recall Summary

Recall Number D-1287-2015
Classification Class III — Low risk
Date Initiated June 30, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GlaxoSmithkline Consmer Healthcare
Location Moon Township, PA
Product Type Drugs
Quantity 17,675 cases

Product Description

Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03) and c) 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04) bottles, Distributed by: GlaxoSmithKline Consumer Healthcare L.P, Moon Township, PA 15108

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Puerto Rico and Virgin Islands

Lot / Code Information

a) 13034 exp 10/31/15, 13222 and 13337 exp 11/30/15, 13611 and 13760 exp 2/29/15, 13953 exp 4/30/16, and 14542 exp 1/31/17; b) BT10114001 and BT10115001A exp 2/1/18, 13316 and 13438 exp 11/30/15 and 13880 exp 2/29/16; c) 13298 exp 11/30/15 and 13759 exp 4/30/16

Other Recalls from GlaxoSmithkline Consmer Healthcare

Recall # Classification Product Date
D-1323-2015 Class II SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz.... Jul 15, 2015
D-1321-2015 Class II SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 ... Jul 15, 2015
D-1322-2015 Class II SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)... Jul 15, 2015
D-1320-2015 Class II biotene PBF Toothpaste (Plaque-Biofilm Loosenin... Jul 15, 2015
D-1319-2015 Class II biotene Gentle Formula FLUORIDE TOOTHPASTE GENT... Jul 15, 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.