Apotex Recalls Piperacillin and Tazobactam Injection Due to Crystallization Risk
Apotex Corp. is recalling 52,398 vials of Piperacillin and Tazobactam for Injection due to a risk of precipitation or crystallization in IV bags or lines.
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 classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Apotex Corp. is recalling 52,398 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 August 2013 to April 2014.
The recall is issued because the product has the potential to exhibit precipitation or crystallization in the IV bag or IV line upon reconstitution. This physical change in the medication could affect its administration or safety.
Healthcare providers and pharmacies should stop using the affected lots and contact Apotex Corp. for instructions on returning the product. Patients who have received this medication should consult their healthcare provider if they have concerns.
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
- 52,398
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 No. 503B023
- Exp. 08/13
- 503B028
- 503B029
- 503B030
- 503B031
- 503B032
- 503B033
- Exp. 11/13
- 503C001
- 503C002
- 503C003
- 503C004
- Exp. 12/13
- 503C009
- Exp. 01/14
- 503C010
- 503C011
- 503C012
- 503C014
Distribution
Distributed nationwide across the United States.
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