CLASS I Drug recall · Reported 23 May 2018 · FDA Enforcement Report
Piperacillin and Tazobactam for Injection, USP* Single Use Vials recalled
Apotex is recalling Piperacillin and Tazobactam for Injection, USP* Single Use Vials per, distributed nationwide in the US. The recall was initiated on 8 May 2018 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0840-2018
- FDA event ID
- 80063
- Recalling firm
- Apotex, North York
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 8 May 2018
- FDA classified
- 5 Jun 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 8 May 2018 | Recall initiated by company | |
| 23 May 2018 | Published in enforcement report | +15 days |
| 5 Jun 2018 | Classified by FDA | +13 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Which lots are affected?
Lots: 502H001 Exp. 01/2019; 502H003, 502H004, 502H005, Exp. 04/2019; 502H009, 502H012, Exp. 05/2019.
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 80063| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Piperacillin and Tazobactam for Injection, USP* Single Use Vials recalled | Apotex | Potency & Assay | Nationwide |
More recalls from Apotex
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
Other Piperacillin recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Piperacillin and Tazobactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Piperacillin and Tazobactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Piperacillin and Tazobactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Piperacillin and Tazobactam for Injection, UPS per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Piperacillin and Tazobactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |