Drug recall D-0375-2019
Product
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.
Lots and codes
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.
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 287,784 bottles
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 2, 2019
- Terminated
- June 26, 2020
Related products
- Cefdinir – drug information
- NDC 68180-723 Cefdinir · Cefdinir 250 mg/5mL · Lupin Pharmaceuticals, Inc.
- NDC 68180-722 Cefdinir · Cefdinir 125 mg/5mL · Lupin Pharmaceuticals, Inc.