The Recall Desk
SevereFDA (Drugs)·D-1804-2019·Announced 2019-08-21

Infusion Options Recalls Perjeta IV Bags Due to Sterility Concerns

Infusion Options, Inc. is recalling Perjeta 420 mg/250 mL IV bags in New York 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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in IV products) are categorized as Severe.

Plain-English summary

Infusion Options, Inc. is recalling Perjeta 420 mg/250 mL 0.9% NaCl IVPB, a prescription-only intravenous infusion product. The recall was initiated because of a lack of assurance of sterility for the product.

The affected product is distributed in New York only. The recall covers all lots within their expiration dates. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should stop using the affected Perjeta IV bags and contact Infusion Options, Inc. for further instructions or returns.

The recalled product

Product
PERJETA 420 MG/250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — IV Infusion
Hazard

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 76 recalled by Infusion Options, 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 76 products in this recall →

Related recalls

Same manufacturer · Infusion Options, Inc.

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Same hazard · sterility

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