Why it was recalled
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Product description
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use 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) C600173, Exp 08/19; C600218, Exp 09/19; b) C600126, C600127, C600137, C600143, Exp 08/19; C600219, Exp 09/19; C700146, Exp 05/20; C700208, C700209, Exp 09/20.
Where it was sold
Nationwide in the USA 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-0356-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 20, 2018
- FDA report date
- Jan 16, 2019
- Quantity
- a) 8,000 vials; b) 32,045 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0356-2019, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 81796
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot #: a) C600173, Exp 08/19; C600218, Exp 09/19; b) C600126, C600127, C600137, C600143, Exp 08/19; C600219, Exp 09/19; C700146, Exp 05/20; C700208, C700209, Exp 09/20.
- Postal code
- 21202-6174
- Report date
- Jan 16, 2019
- Product type
- Drugs
- Recall number
- D-0356-2019
- Classification
- Class I
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- a) 8,000 vials; b) 32,045 boxes
- Termination date
- Aug 18, 2020
- Reason for recall
- Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use 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 in the USA and Puerto Rico.
- Recall initiation date
- Dec 20, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 14, 2019