Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx onl...
FDA Drug Recall #D-806-2013 — Class I — March 18, 2013
Recall Summary
| Recall Number | D-806-2013 |
| Classification | Class I — Serious risk |
| Date Initiated | March 18, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Apotex Corp. |
| Location | Weston, FL |
| Product Type | Drugs |
| Quantity | 37,303 vials |
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.
Reason for Recall
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Distribution Pattern
Nationwide
Lot / 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
Other Recalls from Apotex Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0407-2026 | Class II | Brimonidine Tartrate/Timolol Maleate Ophthalmic... | Mar 5, 2026 |
| D-0676-2025 | Class II | Brimonidine Tartrate/Timolol Maleate Ophthalmic... | Sep 5, 2025 |
| D-0677-2025 | Class II | Ketorolac Tromethamine Ophthalmic Solution, 0.5... | Sep 5, 2025 |
| D-0457-2025 | Class II | Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL... | May 28, 2025 |
| D-0494-2025 | Class II | Ketorolac Tromethamine Ophthalmic Solution, 0.5... | May 28, 2025 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.