Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
Reported: October 23, 2019 Initiated: October 9, 2019 #D-0146-2020
Product Description
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
Reason for Recall
Crystallization: Presence of particulate matter identified as API crystallization
Details
- Recalling Firm
- Ingenus Pharmaceuticals Llc
- Units Affected
- 16485 vials
- Distribution
- U.S.A. Nationwide
- Location
- Orlando, FL
Frequently Asked Questions
What product was recalled? ▼
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839. Recalled by Ingenus Pharmaceuticals Llc. Units affected: 16485 vials.
Why was this product recalled? ▼
Crystallization: Presence of particulate matter identified as API crystallization
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 23, 2019. Severity: Moderate. Recall number: D-0146-2020.
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