SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only...
FDA Drug Recall #D-0298-2019 — Class I — November 15, 2018
Recall Summary
| Recall Number | D-0298-2019 |
| Classification | Class I — Serious risk |
| Date Initiated | November 15, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Fresenius Kabi USA, LLC |
| Location | Grand Island, NY |
| Product Type | Drugs |
| Quantity | 23,745,300 10 mL vials |
Product Description
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
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
Lot / Code Information
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 02/2020 6016077 02/2020 6016104 02/2020 6016208 02/2020 6016209 02/2020 6016210 02/2020 6016258 02/2020 6016259 02/2020 6016260 02/2020 6016261 02/2020 6016262 03/2020 6016263 03/2020 6016264 03/2020 6016323 03/2020 6016324 03/2020 6016325 03/2020 6016383 03/2020 6016384 03/2020 6016385 03/2020 6016386 03/2020 6016387 03/2020 6016388 03/2020 6016389 03/2020 6016584 04/2020 6016585 04/2020 6016621 04/2020 6016622 04/2020 6016623 04/2020 6016765 05/2020 6016766 05/2020 6016767 05/2020 6016768 05/2020 6016769 05/2020 6016875 06/2020 6016876 06/2020 6016877 06/2020 6016878 06/2020 6016879 06/2020 6017288 06/2020 6017289 06/2020 6017290 06/2020 6017291 06/2020 6017382 07/2020 6017425 07/2020 6017426 07/2020 6017427 07/2020 6017428 07/2020 6017429 07/2020 6017470 07/2020 6017471 07/2020 6017472 07/2020 6017473 07/2020 6017474 07/2020 6017675 08/2020 6017725 08/2020 6017726 08/2020 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 non US 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 6016209 02/2020 6016210 02/2020 6016258 02/2020 6016259 02/2020 6016260 02/2020 6016261 02/2020 6016262 03/2020 6016263 03/2020 6016264 03/2020 6016323 03/2020 6016324 03/2020 6016325 03/2020 6016383 03/2020 6016384 03/2020 6016385 03/2020 6016386 03/2020 6016387 03/2020 6016388 03/2020 6016389 03/2020 6016584 04/2020 6016585 04/2020 6016621 04/2020 6016622 04/2020 6016623 04/2020 6016765 05/2020 6016766 05/2020 6016767 05/2020 6016768 05/2020 6016769 05/2020 6016875 06/2020 6016876 06/2020 6016877 06/2020 6016878 06/2020 6016879 06/2020 6017288 06/2020 6017289 06/2020 6017290 06/2020 6017291 06/2020 6017382 07/2020 6017425 07/2020 6017426 07/2020 6017427 07/2020 6017428 07/2020 6017429 07/2020 6017470 07/2020 6017471 07/2020 6017472 07/2020 6017473 07/2020 6017474 07/2020 6017675 08/2020 6017726 08/2020
Other Recalls from Fresenius Kabi USA, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0432-2026 | Class II | 0.9% Sodium Chloride Injection, USP 900 mg per ... | Mar 11, 2026 |
| D-0427-2026 | Class II | 0.9% Sodium Chloride Injection, USP, (2,250 mg ... | Mar 11, 2026 |
| D-0434-2026 | Class II | 0.9% Sodium Chloride Injection, USP 900 mg per ... | Mar 11, 2026 |
| D-0428-2026 | Class II | 0.9% Sodium Chloride Injection, USP, (4,500 mg ... | Mar 11, 2026 |
| D-0424-2026 | Class II | 0.45% Sodium Chloride Injection, USP, 1.125 gra... | Mar 11, 2026 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.