Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, N...

FDA Drug Recall #D-1648-2012 — Class III — July 2, 2012

Recall Summary

Recall Number D-1648-2012
Classification Class III — Low risk
Date Initiated July 2, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hospira Inc.
Location Lake Forest, IL
Product Type Drugs
Quantity 77,542 vials

Product Description

Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL 60045, Product of Australia

Reason for Recall

Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.

Distribution Pattern

Nationwide and Puerto Rico

Lot / Code Information

5 mL vial - NDC 61703-339-18 (Hospira label), lot number Y031654AB, expiration APR2013; NDC 61703-360-18 (Novoplus label), lot number Y031654AA, expiration APR2013; 45 mL vial - NDC 61703-339-50 (Hospira label), lot numbers Y041711AA, expiration DEC 2012 and Y061711AB, expiration FEB 2013; NDC 61703-360-50 (Novoplus label), lot number Y061711AA, expiration FEB 2013

Other Recalls from Hospira Inc.

Recall # Classification Product Date
D-0862-2017 Class I Infant 25% DEXTROSE Injection, USP, 2.5 g (250 ... Apr 21, 2017
D-0153-2017 Class II Fentanyl Citrate Injection, USP, 100 mcg Fentan... Nov 1, 2016
D-1500-2016 Class II DOBUTamine Injection, USP 250 mg/20 mL, 20 mL V... Aug 15, 2016
D-0169-2017 Class III 5% Lidocaine HCL and 7.5% Dextrose Injection, U... Jun 29, 2016
D-1359-2016 Class II Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL)... Jun 23, 2016

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.