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
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
Affected NDC
60505-0688-04
Compare with the code on your package — it is the most precise check available.
Drug: Tazobactam
- Recalling firm
- Apotex Inc.
- NDC code
- 60505-0688-4
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0840-2018 · 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 Inc.
All 2018 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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