D-0146-2020 Class II Terminated
FDA drug recall D-0146-2020 was initiated by Ingenus Pharmaceuticals Llc on October 9, 2019 and is designated Class II. Reason for recall: Crystallization: Presence of particulate matter identified as API crystallization The recall status is terminated (terminated December 1, 2020). Affected quantity: 16485 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- October 23, 2019
- Initiation Date
- October 9, 2019
- Termination Date
- December 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16485 vials
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
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot#: 18048, 18049 Exp. 04/2020; 18050 Exp 05/2020; 19036 Exp 12/2020