Recalls / Class III
Class IIID-1036-2018
Product
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; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.
- Brand name
- Levofloxacin
- Generic name
- Levofloxacin
- Active ingredient
- Levofloxacin
- Route
- Intravenous
- NDCs
- 36000-045, 36000-046, 36000-047, 36000-048
- FDA application
- ANDA091436
- Affected lot / code info
- Lot #: A060940, A060948, A060951, A060956, A060958, A060963, Exp 07/18; A061105, A061110, A061113, A061115, A061119, Exp 08/18; A061243, Exp 09/18; A0A0813, Exp 07/19; A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925, Exp 08/19; A0A0971, A0A0976, Exp 09/19; A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, A0A1004, Exp 10/19.
Why it was recalled
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 711,216 bags
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2018-08-01
- FDA classified
- 2018-08-03
- Posted by FDA
- 2018-08-15
- Terminated
- 2020-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1036-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.