D-0306-2020 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2019
- Initiation Date
- November 1, 2019
- Termination Date
- March 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 4074 bottles b) 30,300 bottles
Product Description
Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA
Reason for Recall
Presence of Foreign substance: identified as a dead ant.
Distribution Pattern
Product was distributed to major distributors/wholesalers throughout the United States.
Code Information
Lot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20