Reported Jan 25, 2023 · Terminated
Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ…
Macleods Pharma USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MACLEODS PHARMA USA, INC · 103 College Rd E Fl 2 · Princeton, NJ · 08540-6611
Is this the product you have?
- Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only
- Manufactured forMacleods Pharma USA, Inc. Princeton, NJ 08540
- Manufactured byMacleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08
- Lot codes and dates
Lot #: BLF2214AExp. 06/2025
- Amount recalled
- 10052 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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