Recalls / Class II
Class IID-1320-2019
Product
Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20
- Brand name
- Cefdinir
- Generic name
- Cefdinir
- Active ingredient
- Cefdinir
- Route
- Oral
- NDCs
- 68180-722, 68180-723
- FDA application
- ANDA065259
- Affected lot / code info
- Lot # F802335, exp. date November 2020
Why it was recalled
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 18,408, 60 mL bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2019-05-23
- FDA classified
- 2019-05-30
- Posted by FDA
- 2019-06-05
- Terminated
- 2020-10-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1320-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.