The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1112-2022·Announced 2022-06-15

Geodon antipsychotic injection recalled nationwide due to manufacturing temperature violations

Geodon for injection (ziprasidone hydrochloride) 20 mg/mL vials are being recalled nationwide due to cGMP deviations involving temperature abuse. The FDA classified this as a Class II recall.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—temperature abuse during manufacturing—is a violation of good manufacturing practices. Per the rubric, recalls involving theoretical hazards without reported illness score at most 3 (High).

Plain-English summary

Geodon for injection (ziprasidone hydrochloride), 20 mg/mL single-dose vials, is being recalled by McKesson Medical-Surgical Inc. due to cGMP (current good manufacturing practice) deviations. The specific deviation identified is temperature abuse during manufacturing and distribution.

The product was distributed nationwide to healthcare facilities and pharmacies. The manufacturer is Viatris. McKesson Medical-Surgical is unable to identify the specific lot numbers of affected product. Instead, customers received notification letters indicating the date product was distributed to them and the dates that affected product may have been shipped to their location.

The FDA has classified this as a Class II recall. The affected product NDC number is 0049-3920-83. Healthcare providers and facilities should contact McKesson Medical-Surgical with questions regarding potentially affected product received at their location.

The recalled product

Product
GEODON (ZIPRASIDONE HYDROCHLORIDE)
Brand
GEODON
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Psychiatric Medication / Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

UPCs (11)

  • 0300490056601
  • 0300490058605
  • 3304023990605
  • 0300490354608
  • 3304023960608
  • 0300490352604
  • 0300490054607
  • 0300490052603
  • 0300490356602
  • 0300490358606
  • 3304023980606

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 130 products in this recall →

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