Status
Completed
Drug Enforcement D-0435-2023
Labeling: Not elsewhere classified
Classification
Class II
Report Date
March 15, 2023
Termination Date
—
Product Information
- 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
- Product quantity
- 28,875 vials
- Reason for recall
- Labeling: Not elsewhere classified
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA Nationwide
Location & Firm
- Recalling firm
- Sagent Pharmaceuticals Inc
- Address
-
1901 N Roselle Rd Ste 450
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0435-2023
- Event ID
- 91789
- Recall initiation date
- February 28, 2023
- Center classification date
- March 6, 2023
- Code info
- Lot#: WP201, Exp 2/2024
- More code info
- —