Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.
Reported: August 30, 2023 Initiated: August 14, 2023 #D-1103-2023
Product Description
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.
Reason for Recall
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 13,502 vials
- Distribution
- Nationwide in the U.S.A.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.. Recalled by Baxter Healthcare Corporation. Units affected: 13,502 vials.
Why was this product recalled? ▼
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 30, 2023. Severity: Low. Recall number: D-1103-2023.
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