Class II · Moderate risk Terminated
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA…
Reason Lack of Assurance of Sterility
Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
What was recalled
Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Recalling firm
- American Pharmaceutical Ingredients LLC
- NDC code
- 58597-8084-1
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0501-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Leucovorin recalls
See all
Class II · Moderate risk Terminated
Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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