Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
Reported: May 22, 2024 Initiated: April 24, 2024 #D-0497-2024
Product Description
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
Reason for Recall
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 17,040 bottles
- Distribution
- USA nationwide
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 17,040 bottles.
Why was this product recalled? ▼
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 22, 2024. Severity: Moderate. Recall number: D-0497-2024.
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