Class I
Terminated
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- June 28, 2019
- Posted
- July 24, 2019
- Recall Number
- D-1489-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,016 vials
- Firm Location
- Melrose Park, IL, United States
Reason for Recall
Presence of Particulate Matter; glass particulates
Distribution
Nationwide USA and Puerto Rico
Lot / Code Info
Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761
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