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
Reported: January 25, 2023 Initiated: January 5, 2023 #D-0162-2023
Product Description
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
Reason for Recall
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Details
- Recalling Firm
- MACLEODS PHARMA USA, INC
- Units Affected
- 10052 bottles
- Distribution
- Nationwide within United States and Puerto Rico.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by MACLEODS PHARMA USA, INC. Units affected: 10052 bottles.
Why was this product recalled? ▼
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2023. Severity: Low. Recall number: D-0162-2023.
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