Recall: D-0306-2020

Class III - Minor Violations

Class IIIClassification

2019-11-01Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA

Reason

Presence of Foreign substance: identified as a dead ant.

Distribution

Product was distributed to major distributors/wholesalers throughout 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.