D-0375-2019 Class II Terminated
FDA drug recall D-0375-2019 was initiated by Lupin Pharmaceuticals Inc. on January 2, 2019 and is designated Class II. Reason for recall: CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. The recall status is terminated (terminated June 26, 2020). Affected quantity: 287,784 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 16, 2019
- Initiation Date
- January 2, 2019
- Termination Date
- June 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 287,784 bottles
Product Description
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Reason for Recall
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Distribution Pattern
Nationwide within the United States
Code Information
a) Lot #: F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F700958, Exp. April 2019 b) Lot #: F700327, F700392, F700393, Exp. January 2019; F700546, F700547, F700664, Exp. March 2019; F700967, Exp. April 2019, F701106, F701107, F701108, F701109, Exp. May 2019.