D-0299-2019 Class I Terminated
FDA drug recall D-0299-2019 was initiated by Fresenius Kabi USA, LLC on Nov 15, 2018 and is designated Class I. Reason for recall: Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not… The recall status is terminated (terminated May 1, 2023). Affected quantity: 1,312,350 20 mL vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 12, 2018
- Initiation Date
- Nov 15, 2018
- Termination Date
- May 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,312,350 20 mL vials
Product Description
SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 918620
Reason for Recall
Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
Distribution Pattern
Distributed Nationwide in the USA and Puerto RIco
Code Information
Lot# EXP date: 6013062 11/2018 6014162 05/2019 6014163 05/2019 6014164 05/2019 6014377 06/2019 6014378 06/2019 6014379 06/2019 6016005 02/2020 6016071 02/2020 6016072 02/2020 6016073 02/2020 6017383 07/2020 6017384 07/2020 6017422 07/2020 6017423 07/2020 6017424 07/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0299-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026