Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, In…
Lupin Pharmaceuticals Inc. · Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Status
- Terminated
- City
- Baltimore
- State
- MD
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 94492
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Address 1
- Harborplace Tower
- Address 2
- 111 S Calvert St Fl 21st
- Postal code
- 21202-6174
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- USA nationwide
- Recall number
- D-0497-2024
- Product quantity
- 17,040 bottles
- Reason for recall
- Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Recall initiation date
- 20240424
- Center classification date
- 20240514
- Termination date
- 20250429
- Report date
- 20240522
- Code info
- Lot # F305292, Exp 8/30/2025
- Product description
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
- Harmonized identifiers (openFDA)
- Application number
- ANDA065259
- Brand name
- CEFDINIR
- Generic name
- CEFDINIR
- Manufacturer name
- Lupin Pharmaceuticals, Inc.
- Product NDC
- 68180-722, 68180-723
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- CEFDINIR
- RxCUI
- 309054, 476576
- SPL ID
- b32b7bfb-4770-4da0-8c48-684233cd10c9
- SPL set ID
- 7490df67-56c0-4a1c-8533-2107f3e8aea5
- Package NDC
- 68180-722-20, 68180-722-10, 68180-722-04, 68180-722-05, 68180-723-20, 68180-723-10, 68180-723-04, 68180-723-05
- Is original packager
- true
- Upc
- 0368180723042
- Nui
- N0000175488, M0003827
- Pharm class epc
- Cephalosporin Antibacterial [EPC]
- Pharm class cs
- Cephalosporins [CS]
- UNII
- CI0FAO63WC