FDA recall D-1320-2019

Product

Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20

Reason for recall

Complaint received of metal piece identified in the product bottle prior to the reconstitution.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-05-23

Report date

2019-06-05

Termination date

2020-10-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1320-2019