US Drug Recall Register
Class III · Low risk Terminated Initiated Nov 1, 2019 (7 years ago)

Cefdinir for Oral Suspension USP

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Presence of Foreign substance: identified as a dead ant.

What was recalled

Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10

Recalling firm
Lupin Pharmaceuticals Inc.
NDC code
68180-723-10
Origin
MD, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0305-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Cefdinir recalls

See all
Class II · Moderate risk Terminated

Cefdinir for Oral Suspension USP

Reason Defective container: lack of seal integrity.

Lupin Pharmaceuticals Inc. NDC 68180-723-04 D-0518-2024
Class II · Moderate risk Terminated

Cefdinir for Oral Suspension USP 125 mg/5 mL

Reason Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Lupin Pharmaceuticals Inc. NDC 68180-722-04 D-0497-2024
Class II · Moderate risk Terminated

Cefdinir for Oral Suspension USP 250 mg/5 mL

Reason Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Lupin Pharmaceuticals Inc. NDC 68180-723-04 D-0496-2024
Class II · Moderate risk Terminated

Cefdinir for Oral Suspension USP

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

Lupin Pharmaceuticals Inc. NDC 68180-723-20 D-1406-2020
Class III · Low risk Terminated

Cefdinir for Oral Suspension USP

Reason Presence of Foreign substance: identified as a dead ant.

Lupin Pharmaceuticals Inc. NDC 68180-722-20 D-0306-2020