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
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG / 50 ml D5W IVPB; LEUCOVORIN 840 MG / 250 ml NS IVPB; LEUCOVORIN 750 MG / 250 ml NS IVPB; LEUCOVORIN 690 MG / 250 ml NS IVPB; LEUCOVORIN 314 mg / 50 ml NS IVPB; LEUCOVORIN 620 MG / 250 ml D5W IVPB; LEUCOVORIN 420 MG / 50 ML D5W IVPB; LEUCOVORIN 700 MG / 250 ml D5W IVPB; LEUCOVORIN 592 mg / 250 ml D5W IVPB; LEUCOVORIN 760 mg / 250 ml D5W IVPB; LEUCOVORIN 796 MG / 250 ml D5W IVPB; LEUCOVORIN 730 MG / 250 ml D5W IVPB; LEUCOVORIN 324 mg / 50 ml NS IVPB; LEUCOVORIN 590 MG / 250 ml D5W IVPB; LEUCOVORIN 336 MG / 50 ml NS IVPB; LEUCOVORIN 398 MG/ 250 ml D5W IVPB; LEUCOVORIN 354 MG / 50 ml NS IVPB; LEUCOVORIN 720 MG / 250 ml D5W IVPB; LEUC; VORIN 328 mg / 50 ml NS IVPB; LEUCOVORIN 776 MG / 250 ml D5W IVPB; LEUCOVORIN 339 MG / 250 ml D5W IVPB; LEUCOVORIN 800 mg / 250 ml D5W IVPB; LEUCOVORIN 330 MG / 50 ml D5W IVPB; LEUCOVORIN 330 MG / 50 ml NS IVPB; LEUCOVORIN 688 MG in 250 ML D5W IVPB; LEUCOVORIN 350 MG / 250 ml NS IVPB; LEUCOVORIN 672 MG / 250 ml D5W IVPB; LEUCOVORIN 588 mg / 250 ml D5W IVPB; LEUCOVORIN 812 MG / 250 ML D5W IVPB; LEUCOVORIN 300 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
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.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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