Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ...

FDA Drug Recall #D-882-2013 — Class III — June 14, 2013

Recall Summary

Recall Number D-882-2013
Classification Class III — Low risk
Date Initiated June 14, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Boehringer Ingelheim Roxane Inc
Location Columbus, OH
Product Type Drugs
Quantity 14,619 cartons

Product Description

Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20

Reason for Recall

Labeling: Missing Label; missing label on blister card

Distribution Pattern

Nationwide

Lot / Code Information

The affected product consists of lot #261739A, expiration date OCT 2014.

Other Recalls from Boehringer Ingelheim Roxane Inc

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D-0011-2016 Class III FUROSEMIDE Tablets USP, 20 mg, 1000-count bottl... Sep 25, 2015
D-1279-2015 Class II COMBIVENT RESPIMAT (ipratropium bromide and alb... Jul 24, 2015
D-1085-2015 Class II Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tabl... Apr 2, 2015
D-1486-2014 Class III OXYCODONE HYDROCHLORIDE C II Oral Solution USP,... Jul 28, 2014

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.