Recalls / Class II
Class IID-0376-2019
Product
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
- Brand name
- Cefdinir
- Generic name
- Cefdinir
- Active ingredient
- Cefdinir
- Route
- Oral
- NDCs
- 68180-722, 68180-723
- FDA application
- ANDA065259
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 287,784 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-01-02
- FDA classified
- 2019-01-15
- Posted by FDA
- 2019-01-16
- Terminated
- 2020-06-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0376-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.