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Recall Observatory FDA recall evidence

Drug product

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

D-0435-2023

February 28, 2023

Class II

Product summary

Firm
Sagent Pharmaceuticals Inc
Event
Event 91789
Status
Terminated
Classification
Class II
Quantity
28,875 vials
Official record key
drug-enforcement:D-0435-2023

Official wording

Reason: Labeling: Not elsewhere classified

Code information: Lot#: WP201, Exp 2/2024

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Not elsewhere classified