Why it was recalled
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Product description
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.
Lot numbers, UPCs & expiration codes
Lot #: B4000935, Exp 01/17; B4005178, Exp 06/17; B4008730, B4008729, B4008727, B4008724, Exp 10/17; B5001647, B5001648, B5001649, Exp 02/18
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-0955-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 11, 2016
- FDA report date
- Jun 8, 2016
- Quantity
- 741.171 kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0955-2016, 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 #: B4000935, Exp 01/17; B4005178, Exp 06/17; B4008730, B4008729, B4008727, B4008724, Exp 10/17; B5001647, B5001648, B5001649, Exp 02/18
- Postal code
- 21202-6174
- Report date
- Jun 8, 2016
- Product type
- Drugs
- Recall number
- D-0955-2016
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 741.171 kg
- Termination date
- Aug 14, 2017
- Reason for recall
- CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 11, 2016
- Initial firm notification
- Center classification date
- Jun 2, 2016