SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610
Check against the official notice below — it lists the full affected range.
Fresenius Kabi USA, LLC is recalling Sodium Chloride Injection, USP 0.9% in 10 mL single-dose vials due to incorrect labeling on certain product codes. The product insert for product codes 918610 and 918620, along with tray labels for those same codes and the vial label for product code 918620, incorrectly state that the stoppers do not contain natural rubber latex. However, the stoppers in the recalled batches actually do contain natural rubber latex, which is significant for patients with latex allergies. The recall affects approximately 23.7 million vials distributed nationwide in the USA and Puerto Rico, with expiration dates ranging from November 2018 through February 2020.
The recall notice does not specify any remedy or recommended action for consumers or healthcare providers who may have the affected product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Distributed Nationwide in the USA and Puerto RIco Quantity: 23,745,300 10 mL vials Lot/code info: Lot# EXP date: 6013112 11/2018 6013113 11/2018 6013114 11/2018 6013180 11/2018 6013181 11/2018 6013182 11/2018 6013237 01/2019 6013238 01/2019 6013239 01/2019 6013468 02/2019 6013512 02/2019 6013513 02/2019 6013551 02/2019 6013552 02/2019 6013553 02/2019 6013607 02/2019 6013608 02/2019 6013610 02/2019 6013627 03/2019 6013678 03/2019 6013679 03/2019 6013822 03/2019 6013823 03/2019 6013824 03/2019 6013924 04/2019 6013925 04/2019 6013926 04/2019 6014003 05/2019 6014004 05/2019 6014005 05/2019 6014260 05/2019 6014301 05/2019 6014302 05/2019 6014303 06/2019 6014304 06/2019 6014305 06/2019 6014306 06/2019 6014307 06/2019 6014384 06/2019 6014404 06/2019 6014405 06/2019 6014453 06/2019 6014454 06/2019 6014455 06/2019 6014479 06/2019 6014557 07/2019 6014558 07/2019 6014606 07/2019 6014649 08/2019 6014650 08/2019 6014704 08/2019 6014766 08/2019 6014767 08/2019 6014768 08/2019 6014841 08/2019 6014842 08/2019 6014843 08/2019 6014861 08/2019 6014862 08/2019 6014863 08/2019 6015049 09/2019 6015050 09/2019 6015088 09/2019 6015118 10/2019 6015127 10/2019 6015128 10/2019 6015186 10/2019 6015187 10/2019 6015188 10/2019 6015233 10/2019 6015234 10/2019 6015235 10/2019 6015285 11/2019 6015286 11/2019 6015287 11/2019 6015408 11/2019 6015409 11/2019 6015410 11/2019 6015452 11/2019 6015453 11/2019 6015454 11/2019 6015572 11/2019 6015573 12/2019 6015574 12/2019 6015616 12/2019 6015617 12/2019 6015618 12/2019 6015922 01/2020 6015923 01/2020 6015924 01/2020 6016002 02/2020 6016003 02/2020 6016004 02/20
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.