D-1406-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 29, 2020
- Initiation Date
- July 2, 2020
- Termination Date
- June 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,928 bottles
Product Description
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 Pattern
U.S.A. Nationwide
Code Information
Lot # F802189, Exp 10/2020, F900240, Exp 1/2021