Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Piperacillin and Tazobactam for Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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
Affected NDC
60505-0773-00
Compare with the code on your package — it is the most precise check available.
Drug: Tazobactam
- Recalling firm
- Apotex Corp.
- NDC code
- 60505-0773-0
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-835-2013 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tazobactam recalls
See all
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Other recalls by Apotex Corp.
All 2013 recalls
Class II · Moderate risk
Paxil CR
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Class II · Moderate risk
Desmopressin Nasal Spray
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Lack of Assurance of Sterility
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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