Why it was recalled
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # F802335, exp. date November 2020
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1320-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 23, 2019
- FDA report date
- Jun 5, 2019
- Quantity
- 18,408, 60 mL bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1320-2019, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 82939
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot # F802335, exp. date November 2020
- Postal code
- 21202-6174
- Report date
- Jun 5, 2019
- Product type
- Drugs
- Recall number
- D-1320-2019
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 18,408, 60 mL bottles
- Termination date
- Oct 22, 2020
- Reason for recall
- Complaint received of metal piece identified in the product bottle prior to the reconstitution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- May 23, 2019
- Initial firm notification
- Letter
- Center classification date
- May 30, 2019