The Recall Desk
SevereFDA (Drugs)·D-0558-2016·Announced 2016-01-06

Walgreens Recalls 3-in-1 TPN Formula Bags Due to Sterility Concerns

Walgreens Infusion Services is recalling 87 bags of 3-in-1 TPN formula in Texas due to a lack of assurance of sterility.

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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a parenteral nutrition product, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

Walgreens Infusion Services is recalling 87 bags of 3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only. The product was compounded by Option Care 148 in San Antonio, Texas. The recall is being conducted because of a lack of assurance of sterility.

The affected product is distributed in Texas. The recall covers all lots within the expiry date. The FDA has classified this recall as Class II.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to proceed.

The recalled product

Product
3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Affected units
87

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 →