Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For ...

FDA Drug Recall #D-0435-2023 — Class II — February 28, 2023

Recall Summary

Recall Number D-0435-2023
Classification Class II — Moderate risk
Date Initiated February 28, 2023
Status Completed
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Sagent Pharmaceuticals Inc
Location Schaumburg, IL
Product Type Drugs
Quantity 28,875 vials

Product Description

Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01

Reason for Recall

Labeling: Not elsewhere classified

Distribution Pattern

USA Nationwide

Lot / Code Information

Lot#: WP201, Exp 2/2024

Other Recalls from Sagent Pharmaceuticals Inc

Recall # Classification Product Date
D-0764-2023 Class II Nafcillin for Injection, USP, 10 gram per Pharm... May 19, 2023
D-0762-2023 Class II Nafcillin for Injection, USP, 1 gram per vial, ... May 19, 2023
D-0763-2023 Class II Nafcillin for Injection, USP, 2 gram per vial, ... May 19, 2023
D-0305-2021 Class II Phenylephrine HCl Injection, USP, 10 mg per mL,... Mar 11, 2021
D-1274-2019 Class II Ketorolac Tromethamine Injection, USP, 60 mg pe... Apr 30, 2019

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.