PlainRecalls
FDA Drug Moderate Class II Terminated

Cefdinir for Oral Suspension USP 250 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 68180-723-04

Reported: May 22, 2024 Initiated: April 24, 2024 #D-0496-2024

Product Description

Cefdinir for Oral Suspension USP 250 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 68180-723-04

Reason for Recall

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Details

Units Affected
17,070 bottles
Distribution
USA nationwide
Location
Baltimore, MD

Frequently Asked Questions

What product was recalled?
Cefdinir for Oral Suspension USP 250 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 68180-723-04. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 17,070 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-0496-2024.