Ingenus Recalls Leucovorin Calcium Injection Due to Crystallization
Ingenus Pharmaceuticals is recalling Leucovorin Calcium Injection vials due to the presence of particulate matter identified as API crystallization.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that could cause temporary or medically reversible adverse health consequences. The hazard is particulate matter (crystallization) without reported injuries or deaths, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Ingenus Pharmaceuticals, LLC is recalling 16,485 vials of Leucovorin Calcium Injection, USP 500 mg/50 mL (10 mg/mL) 50 mL Single-Dose Vials. The recall is being conducted because of the presence of particulate matter identified as active pharmaceutical ingredient (API) crystallization.
The affected product is distributed nationwide in the United States. The specific lots involved are 18048 and 18049 (expiring 04/2020), 18050 (expiring 05/2020), and 19036 (expiring 12/2020). The NDC for the product is 50742-464-50.
Healthcare providers and patients should discontinue use of the affected vials and contact Ingenus Pharmaceuticals for further instructions or replacement.
The recalled product
- 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
- Manufacturer
- Ingenus Pharmaceuticals Llc
- Category
- Drug — Injection
- Affected units
- 16,485
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot#: 18048
- 18049 Exp. 04/2020
- 18050 Exp 05/2020
- 19036 Exp 12/2020
Distribution
Distributed nationwide across the United States.
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