Recall: D-0496-2024

Class II - Potentially Harmful

Class IIClassification

2024-04-24Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

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

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

Distribution

USA nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.