Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC ...
FDA Drug Recall #D-157-2013 — Class I — November 21, 2012
Recall Summary
| Recall Number | D-157-2013 |
| Classification | Class I — Serious risk |
| Date Initiated | November 21, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bracco Diagnostic Inc |
| Location | Monroe Township, NJ |
| Product Type | Drugs |
| Quantity | 5483 syringes (548.3 boxes) |
Product Description
Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany).
Reason for Recall
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Distribution Pattern
Nationwide.
Lot / Code Information
Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13
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-1536-2014 | Class III | E-Z-HD (barium sulfate) For Suspension (98% w/w... | Jul 2, 2014 |
| 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.