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 No. 503B023, Exp. 08/13; 503B028, 503B029, 503B030, 503B031, 503B032, 503B033, Exp. 11/13; 503C001, 503C002, 503C003, 503C004, Exp. 12/13; 503C009, Exp. 01/14; 503C010, 503C011, 503C012, 503C014, Exp. 02/14; 503C015, 503C016, 503C017, 503C019, 503C020, 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-835-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 10, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 52,398 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-835-2013, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 65196
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lot No. 503B023, Exp. 08/13; 503B028, 503B029, 503B030, 503B031, 503B032, 503B033, Exp. 11/13; 503C001, 503C002, 503C003, 503C004, Exp. 12/13; 503C009, Exp. 01/14; 503C010, 503C011, 503C012, 503C014, Exp. 02/14; 503C015, 503C016, 503C017, 503C019, 503C020, Exp. 04/14
- Postal code
- 33326-3253
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-835-2013
- Classification
- Class I
- Recalling firm
- Apotex Corp.
- Product quantity
- 52,398 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
- May 10, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2013