D-0376-2019 Class II Terminated
FDA drug recall D-0376-2019 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, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), 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 #: F700343, F700344, F700345, F700346, F700347,F700376, F700377, F700415, F700146,F700417, F700418, Exp. Jan 2019; F700419, F700420, F700492, F700493,F700508,F700665, Exp. February 2019; F700784, Exp. April 2019; b) Lot #: F700324, F700325, F700326, Exp. January 2019; F700618, F700619, F700620, Exp. February 2019.