Recall: D-0376-2019

Class II - Potentially Harmful

Class IIClassification

2019-01-02Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA

Reason

CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.

Distribution

Nationwide within the United States

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