The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0536-2016·Announced 2016-01-06

Meropenem Infusion Minibags Recalled for Sterility Assurance Concerns

Walgreens Infusion Services is recalling 35 Meropenem minibags distributed 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 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 II, and the hazard involves a lack of assurance of sterility in an infusion product, which poses a significant risk of serious injury or hospitalization if contaminated.

Plain-English summary

Walgreens Infusion Services is recalling 35 units of Meropenem 1 g/NS 100 mL Minibag Plus. The product is compounded by Option Care 148 in San Antonio, Texas, and was distributed in Texas. The recall is being conducted due to a lack of assurance of sterility.

The source text does not specify which lots are affected, stating only that all lots within expiry are included. No specific dates, lot numbers, or additional distribution details are provided in the notice.

Consumers and healthcare providers should stop using the affected product 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
Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Affected units
35

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 →

Similar recalls