Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-04

FDA recall notice · announced August 15, 2018 · Baxter Healthcare

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.

Reason for recall

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

Notes

Distribution: Nationwide USA and Puerto Rico
Lot/code information: Lot #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19
Quantity: 191,256 bags
Status: Terminated
Products in this recall event:
- Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; (D-1036-2018)
- Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; (D-1035-2018)
- Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By (D-1034-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.