Leucovorin Calcium Injection recall: Particulate Matter
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…
Why was Leucovorin Calcium Injection recalled?
Crystallization: Presence of particulate matter identified as API crystallization
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 18048, 18049 Exp. 04/2020; 18050 Exp 05/2020; 19036 Exp 12/2020
- Product
- 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…
- Recalling firm
- Ingenus Pharmaceuticals Llc
- Quantity
- 16485 vials
- Distribution
- U.S.A. Nationwide
- Recall date
- October 23, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)