Why it was recalled
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Product description
Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Lot numbers, UPCs & expiration codes
Lot #: a) C500006, Exp 11/17; b) C500001, Exp 11/17
Where it was sold
Nationwide and Puerto Rico
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-0952-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 11, 2016
- FDA report date
- Jun 8, 2016
- Quantity
- 7908 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0952-2016, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 73830
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot #: a) C500006, Exp 11/17; b) C500001, Exp 11/17
- Postal code
- 21202-6174
- Report date
- Jun 8, 2016
- Product type
- Drugs
- Recall number
- D-0952-2016
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 7908 vials
- Termination date
- Aug 14, 2017
- Reason for recall
- CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 11, 2016
- Initial firm notification
- Center classification date
- Jun 2, 2016