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, Lyophilized 100 Mg Vial Injectable 1 Vial 10 Vial 100 Vial 2 Vial…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
What was recalled
LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL 2 VIAL 24 VIAL 30 VIAL 50 VIAL 60 VIAL 76 VIAL; LEUCOVORIN, LYOPHILIZED 350 MG VIAL INJECTABLE 10 VIAL 15 VIAL 20 VIAL 22 VIAL 28 VIAL 30 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 8 VIAL; LEUCOVORIN, LYOPHILIZED 500 MG VIAL INJECTABLE 10 VIAL 14 VIAL 15 VIAL 17 VIAL 2 VIAL 20 VIAL 23 VIAL 25 VIAL 27 VIAL 3 VIAL 30 VIAL 33 VIAL 36 VIAL 5 VIAL 50 VIAL (35 DIFFERENT PRODUCTS)
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1555-2012
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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