Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only,...

FDA Drug Recall #D-1372-2020 — Class III — June 10, 2020

Recall Summary

Recall Number D-1372-2020
Classification Class III — Low risk
Date Initiated June 10, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm American Health Packaging
Location Columbus, OH
Product Type Drugs
Quantity 265 cartons

Product Description

Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11

Reason for Recall

Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.

Distribution Pattern

Nationwide USA

Lot / Code Information

Lot #: 189551, Exp 04/30/2021

Other Recalls from American Health Packaging

Recall # Classification Product Date
D-0880-2022 Class III Nitrofurantoin Capsules, USP (Monohydrate/Macro... May 3, 2022
D-0790-2022 Class III Cyanocobalamin Injection, USP, 1000 mcg per mL,... Apr 12, 2022
D-0652-2022 Class II Oxycodone Hydrochloride Oral Solution, USP (C-I... Feb 22, 2022
D-0451-2022 Class II Metoprolol Succinate Extended-Release Tablets, ... Dec 20, 2021
D-0020-2022 Class II GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 ... Sep 17, 2021

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced 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.