D-1252-2020 Class II Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

Recall Details

Product Type
Drugs
Report Date
April 29, 2020
Initiation Date
April 15, 2020
Termination Date
June 7, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,518 bottles

Product Description

Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01

Reason for Recall

Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

Distribution Pattern

Nationwide with the United States and Puerto Rico.

Code Information

Lot #: F800779, Expiry 4/2020