Recall: D-1406-2020

Class II - Potentially Harmful

Class IIClassification

2020-07-02Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

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

Distribution

U.S.A. 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.