FDA-Drug2023-01-25Class III
Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08
MACLEODS PHARMA USA, INC
Hazard
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Sold states
Nationwide within United States and Puerto Rico.
Affected count
10052 bottles
Manufactured in
103 College Rd E Fl 2, N/A, Princeton, NJ, United States
Products
Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0162-2023Don't want to check this manually?
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