Why it was recalled
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Product description
Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.
Lot numbers, UPCs & expiration codes
Lot #: 503B015, 503B016, Exp 04/13; 503B019, 503B020, 503B021, 503B022, Exp 07/13; 503B024, Exp 08/13; 503B025, 503B026, 503B027, Exp 09/13; 503C005, 503C006, Exp 12/13; 503C007, 503C008, Exp 01/14; 503C018, Exp 04/14
Where it was sold
Nationwide
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-806-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 18, 2013
- FDA report date
- Jul 24, 2013
- Quantity
- 37,303 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-806-2013, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 64657
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lot #: 503B015, 503B016, Exp 04/13; 503B019, 503B020, 503B021, 503B022, Exp 07/13; 503B024, Exp 08/13; 503B025, 503B026, 503B027, Exp 09/13; 503C005, 503C006, Exp 12/13; 503C007, 503C008, Exp 01/14; 503C018, Exp 04/14
- Postal code
- 33326-3253
- Report date
- Jul 24, 2013
- Product type
- Drugs
- Recall number
- D-806-2013
- Classification
- Class I
- Recalling firm
- Apotex Corp.
- Product quantity
- 37,303 vials
- Termination date
- Jan 8, 2018
- Reason for recall
- Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2013