The Recall Desk
ModerateFDA (Drugs)·D-0738-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Polyethylene Glycol 3350 Powder Due to Processing Controls

Kroger Specialty Pharmacy is recalling Polyethylene Glycol 3350 powder for solution due to a lack of processing controls. The product was distributed in five states.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply (NDC 51991-0457-57). The recall was initiated due to a lack of processing controls.

The affected product was dispensed between December 1, 2017, and February 12, 2018. It was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The recall includes all lots remaining within their expiry date that were dispensed during this period.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57

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 remaining within expiry dispensed 12/01/2017 through 02/12/2018

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 67 recalled by Kroger Specialty Pharmacy, Inc. 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 67 products in this recall →