FDA recall D-1406-2020

Product

Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20

Reason for recall

Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2020-07-02

Report date

2020-07-29

Termination date

2021-06-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1406-2020