E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM C...

FDA Drug Recall #D-1536-2014 — Class III — July 2, 2014

Recall Summary

Recall Number D-1536-2014
Classification Class III — Low risk
Date Initiated July 2, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bracco Diagnostic Inc
Location Monroe Township, NJ
Product Type Drugs
Quantity 216,792 bottles

Product Description

E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.

Reason for Recall

Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.

Distribution Pattern

Nationwide and Puerto Rico

Lot / Code Information

Lot #'s: 64205, 64206, 64200, 64201, 64202, 64203, 64204, 64207, 64264, Exp 05/15; 64265, 64267, 64268, 64270, 64271, Exp 06/15

Other Recalls from Bracco Diagnostic Inc

Recall # Classification Product Date
D-1147-2015 Class III E-Z-CAT Dry Barium Sulfate for Suspension (2% w... May 27, 2015
D-0014-2015 Class III E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antif... Sep 18, 2014
D-157-2013 Class I Isovue -370 (Iopamidol) Injection 76%, Prefille... Nov 21, 2012
D-158-2013 Class I Isovue -300 (Iopamidol) Injection 61% Prefilled... Nov 21, 2012
D-095-2013 Class III Choletec - Kit for the Preparation of Technetiu... Aug 14, 2012

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.