Recalls / Class II
Class IID-0146-2020
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 32839
- Affected lot / code info
- Lot#: 18048, 18049 Exp. 04/2020; 18050 Exp 05/2020; 19036 Exp 12/2020
Why it was recalled
Crystallization: Presence of particulate matter identified as API crystallization
Recalling firm
- Firm
- Ingenus Pharmaceuticals Llc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4190 Millenia Blvd, N/A, Orlando, Florida 32839-6408
Distribution
- Quantity
- 16485 vials
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-10-09
- FDA classified
- 2019-10-17
- Posted by FDA
- 2019-10-23
- Terminated
- 2020-12-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0146-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.