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, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); 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) C600110, Exp 05/19; C600130, Exp 08/19; C700113, Exp 03/20; C700143, Exp 05/20; b) C600106, C600108, Exp 05/19; C600128, C600138, Exp 08/19; C600174, C600179, C600180, C600181, Exp 09/19; C700108, C700109, C700110, C700111, C700112, Exp 03/20; C700129, C700130, C700131, C700132, C700138, C700142, C700145, Exp 05/20
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-0357-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 20, 2018
- FDA report date
- Jan 16, 2019
- Quantity
- a) 35,000 vials; b) 112,641 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0357-2019, 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) C600110, Exp 05/19; C600130, Exp 08/19; C700113, Exp 03/20; C700143, Exp 05/20; b) C600106, C600108, Exp 05/19; C600128, C600138, Exp 08/19; C600174, C600179, C600180, C600181, Exp 09/19; C700108, C700109, C700110, C700111, C700112, Exp 03/20; C700129, C700130, C700131, C700132, C700138, C700142, C700145, Exp 05/20
- Postal code
- 21202-6174
- Report date
- Jan 16, 2019
- Product type
- Drugs
- Recall number
- D-0357-2019
- Classification
- Class I
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- a) 35,000 vials; b) 112,641 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, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); 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