Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
Reported: April 29, 2020 Initiated: April 15, 2020 #D-1252-2020
Product Description
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
Reason for Recall
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 4,518 bottles
- Distribution
- Nationwide with the United States and Puerto Rico.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 4,518 bottles.
Why was this product recalled? ▼
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 29, 2020. Severity: Moderate. Recall number: D-1252-2020.
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