UDENYCA syringes recalled after cartons were stored at room temperature
McKesson is recalling 116 cartons of UDENYCA pegfilgrastim-cbqv injection because they were stored in a controlled room temperature environment instead of the required refrigerated environment.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL single dose prefilled syringe, Rx only, manufactured by Accord BioPharma, Inc. of Raleigh, North Carolina, under NDC 69448-025-63, is being recalled by McKesson.
The reason given in the enforcement record is temperature abuse: 116 cartons with specific serial numbers of lot 2199821 were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
The record lists 116 cartons from a subset of lot 2199821, expiring 05/31/2027, with the specific affected serial numbers recorded in the enforcement record. Distribution was nationwide in the USA. The FDA has classified the action as Class I, its most serious category.
Patients should not stop a prescribed treatment without speaking to their prescriber, who can confirm whether an affected carton was used and arrange a replacement.
The recalled product
- Product
- UDENYCA (PEGFILGRASTIM-CBQV)
- Brand
- UDENYCA
- Manufacturer
- McKesson
- Category
- Drug — Biologic injection
- Affected units
- 116
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 (20)
- Subset of Lot 2199821
- Expires: 05/31/2027 Specific Serial Numbers being Recalled: 160R694TT06X
- 1C74A686RPPG
- 1W6A2M777N3V
- 20825394KR8P
- 242E2RK3EA92
- 2DG49VH89EPG
- 2WEA2ADK1P4H
- 3KR2TVAG3VDH
- 42M0V0G9PM84
- 46E9XKDPTH1R
- 4AM12WEAE48H
- 4FGHR096DMNV
- 4MWGWM991XNA
- 4NEW8XD9DNM2
- 4Y2PYDFN9YA1
- 61EPX42R4K2A
- 63FN9VW5CAV7
- 69TG160DW2CV
- 69XFP3TMTP7X
UPCs (1)
- 0369448025632
Distribution
Distributed nationwide across the United States.
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