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.
What this means for you
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
- Hazard
- temperature-abuse
- manufacturing-defect
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.
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