FDAFDA · Food and drugs·Recall number D-1215-2018
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.
Published October 3, 2018 · Recall initiated: September 25, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LEVOFLOXACIN
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Nationwide USA and Puerto Rico
- UPC
- 0336000047241
- Lot
- Lot #: a) A061178, A061183, A061236, Exp. Date 09/2018; A0A0937, Exp. Date 08/2019; A0A1044, A0A1048, Exp. Date 10/2019. b) A0A0741, A0A0747, A0A0748, Exp. Date 6/2019; A0A0814, A0A0815, A0A0823, Exp.Date 7/2019; A0A0889, A0A0893, Exp. Date 8/2019; A0A0954, A0A0958, A0A0970, Exp. Date 09/2019; A0A1005, A0A1006, A0A1008, A0A1012, A0A1016, A0A1028, A0A1036, Exp. 10/2019. c) A061243, Exp. Date 09/2018; A0A0258, Exp. Date 2/2019; A0A0813, Exp. Date 07/2019; A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925, Exp. Date 08/2019; A0A0971, A0A0976, Exp. Date 09/2019; A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, A0A1004, Exp. Date 10/2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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