Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials
Apotex Inc. is recalling specific lots of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are never scored below 4.
Plain-English summary
Apotex Inc. is recalling 13,453 vials of Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial. The product is distributed nationwide in the USA. The recall involves specific lots with expiration dates ranging from January 2019 to May 2019.
The recall was initiated because the drug contains high levels of impurities, which resulted in decreased potency. This means the medication may not be as effective as intended for treating infections.
Healthcare providers and patients should check their inventory for the affected lot numbers and expiration dates. If the product is found, it should be quarantined and not administered. Patients who have already received the medication should contact their healthcare provider for guidance.
The recalled product
- Product
- 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
- Manufacturer
- Apotex Inc.
- Category
- Drug — Antibiotic Injection
- Hazard
- Affected units
- 13,453
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lots: 502H001 Exp. 01/2019
- 502H003
- 502H004
- 502H005
- Exp. 04/2019
- 502H009
- 502H012
- Exp. 05/2019.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Apotex Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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