The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0529-2016·Announced 2016-01-06

Walgreens Recalls Piperacillin/Tazobactam Bags Due to Sterility Concerns

Walgreens Infusion Services is recalling 26 bags of Piperacillin/Tazobactam (Zosyn) Accuflo in Texas due to a lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Walgreens Infusion Services is recalling 26 bags of Piperacillin/Tazobactam (Zosyn) Accuflo, a prescription-only medication. The affected products are compounded by Option Care 148 in San Antonio, Texas, and were distributed within the state of Texas. The recall is being conducted because of a lack of assurance of sterility.

The specific products involved are 18 g/NS 275 mL and 4.5 g/NS 100 mL Accuflo bags. All lots within the expiry date are affected. The source text does not specify a particular lot number or expiration date range beyond stating that all lots within expiry are included.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Manufacturer
Walgreens Infusion Services
Category
Drug — Antibiotic
Hazard
Affected units
26

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 (1)

  • All lots within expiry.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 33 recalled by Walgreens Infusion Services 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.

See all 33 products in this recall →

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