Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Reported: September 4, 2024 Initiated: August 21, 2024 #D-0648-2024
Product Description
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Reason for Recall
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 4554 bottles
- Distribution
- USA nationwide.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 4554 bottles.
Why was this product recalled? ▼
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 4, 2024. Severity: Moderate. Recall number: D-0648-2024.
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