The Recall Desk
SevereFDA (Drugs)·D-0795-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Perjeta Vials Due to Processing Controls

Kroger Specialty Pharmacy is recalling Perjeta 420 mg/14 mL vials due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.

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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe) because the agency's own classification mandates a minimum score of 4.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Perjeta 420 mg/14 mL SDV Vials (NDC 50242-0145-01) because of a lack of processing controls. The recall involves a 21-day supply of the medication.

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

Consumers who have this product should contact their healthcare provider or pharmacist for guidance on what to do next. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply

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 →