Sodium Chloride Injection recall: Labeling Error
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
Why was Sodium Chloride Injection recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 1,312,350 20 mL vials
- Distribution
- Distributed Nationwide in the USA and Puerto RIco
- Recall date
- December 12, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)