Why it was recalled
Presence of Foreign substance: identified as a dead ant.
Product description
Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA
Lot numbers, UPCs & expiration codes
Lot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20
Where it was sold
Product was distributed to major distributors/wholesalers throughout the United States.
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-0306-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 1, 2019
- FDA report date
- Nov 13, 2019
- Quantity
- a) 4074 bottles b) 30,300 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0306-2020, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 84196
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20
- Postal code
- 21202-6174
- Report date
- Nov 13, 2019
- Product type
- Drugs
- Recall number
- D-0306-2020
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- a) 4074 bottles b) 30,300 bottles
- Termination date
- Mar 4, 2021
- Reason for recall
- Presence of Foreign substance: identified as a dead ant.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA
- Distribution pattern
- Product was distributed to major distributors/wholesalers throughout the United States.
- Recall initiation date
- Nov 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 7, 2019