Apotex Recalls Piperacillin and Tazobactam Injection Due to Crystallization Risk
Apotex Corp. is recalling 37,303 vials of Piperacillin and Tazobactam for Injection due to a risk of precipitation or crystallization in IV bags or lines.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, 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 must be scored as at least 4 (Severe).
Plain-English summary
Apotex Corp. is recalling 37,303 vials of Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial. The product is manufactured by Hospira Healthcare India Pvt. Ltd. for Apotex Corp. and is distributed nationwide. The recall involves specific lots with expiration dates ranging from April 2013 to April 2014.
The recall is being conducted because the product has the potential to exhibit precipitation or crystallization in the IV bag or IV line upon reconstitution. This defect could affect the administration of the medication.
Healthcare providers and pharmacies should stop using the affected vials and contact Apotex Corp. for further instructions on returning the product. Patients should consult their healthcare provider if they have received this medication.
The recalled product
- Product
- 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.
- Manufacturer
- Apotex Corp.
- Category
- Drug — Antibiotic Injection
- Affected units
- 37,303
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 (20)
- 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
Distribution
Distributed nationwide across the United States.
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