FDA DrugsClass I
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe,...
Published: February 18, 2026Recall ID: D-0353-2026Category: drugsCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
Affected Products
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
Additional Source Details
| Field | Value |
|---|---|
| City | Irving |
| State | TX |
| Openfda › Nui › 1 | M0024696 |
| Openfda › Nui › 2 | N0000009451 |
| Openfda › Nui › 3 | N0000175666 |
| Openfda › Upc | 0369448025632 |
| Openfda › Unii | 3A58010674 |
| Openfda › Route | SUBCUTANEOUS |
| Openfda › Rxcui › 1 | 2102703 |
| Openfda › Rxcui › 2 | 2102705 |
| Openfda › Rxcui › 3 | 2632544 |
| Openfda › Rxcui › 4 | 2632547 |
| Openfda › Rxcui › 5 | 2673598 |
| Openfda › Rxcui › 6 | 2673602 |
| Openfda › Spl id | b9326155-8307-4ac1-9c13-6598e6c7a361 |
| Openfda › Brand name | UDENYCA |
| Openfda › Spl set id | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 |
| Openfda › Package ndc › 1 | 69448-025-63 |
| Openfda › Package ndc › 2 | 69448-026-63 |
| Openfda › Package ndc › 3 | 69448-027-63 |
| Openfda › Product ndc › 1 | 69448-025 |
| Openfda › Product ndc › 2 | 69448-026 |
| Openfda › Product ndc › 3 | 69448-027 |
| Openfda › Generic name | PEGFILGRASTIM-CBQV |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Granulocyte Colony-Stimulating Factor [CS] |
| Openfda › Pharm class pe | Increased Myeloid Cell Production [PE] |
| Openfda › Substance name | PEGFILGRASTIM |
| Openfda › Pharm class epc | Leukocyte Growth Factor [EPC] |
| Openfda › Manufacturer name | Accord BioPharma, Inc. |
| Openfda › Application number | BLA761039 |
| Openfda › Is original packager | true |
| Event id | 98366 |
| Address 1 | 6555 State Highway 161 |
| Address 2 | N/A |
| Code info | 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; 6AWVDCNHTV61; 6CEFY72W5GPA; 6FHF1A59X0X4; 6GA64FNDVGXY; 6NW5FACPPWDW; 75V19CF2A0PA; 7HK7155YNAK3; 7R51VVA1WX9T; 7XCKXMH2EERC; 85D8MFVM66D4; 8F3Y5NFFHC64; 8RDWKPM53N5R; 8W1PVXC5NAFW; 9338DPED7P3R; 9A4CXFTGCPYN; 9FKN5NRDX99A; 9G79AR0RGAY4; 9K28G80GGYXN; 9NN7NXE40M13; A48PXEPE77YE; A8M168K58G64; AMR0RNWHTWMW; AR145NW8WTVX; AY19W6DEGRX4; C276HMDGRE49; CAY0ARAEGMCF; CKT370X2G4NP; D0DFAXCN6G5W; D54TXR8AD9Y8; DAK3XP1P3DMP; DH44AGKTX27F; E69E9K6C29VD; EK1D8P703RCH; EX947FYVW7Y6; F2K148YVNRDD; F4EVX8573F1V; FEXA7MENKWF1; FNDNMPAFH89D; G2W3WTMP5HK9; G5MN0F418FFY; G6XECANG6P01; G7FNVGWW3D72; GAHFFNX336GA; GKNTDP4AV6AA; GVPN5C4D23H6; GVPPYARK1FCD; GVXDAAA... [TRUNCATED] |
| Postal code | 75039-2402 |
| Report date | 20260218 |
| Product type | Drugs |
| Product quantity | 116 cartons |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260116 |
| Initial firm notification | |
| Center classification date | 20260226 |
Overview
- Recalling FirmMcKesson
- StatusOngoing
- Risk LevelClass I
- DistributionNationwide in the USA