Why it was 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.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Distributed Nationwide in the USA and Puerto RIco
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0299-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 15, 2018
- FDA report date
- Dec 12, 2018
- Quantity
- 1,312,350 20 mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0299-2019, exactly as published.
Show all FDA fields
- City
- Grand Island
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 81570
- Address
- 3159 Staley Rd
- 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
- Postal code
- 14072-2028
- Report date
- Dec 12, 2018
- Product type
- Drugs
- Recall number
- D-0299-2019
- Classification
- Class I
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 1,312,350 20 mL vials
- Termination date
- May 1, 2023
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed Nationwide in the USA and Puerto RIco
- Recall initiation date
- Nov 15, 2018
- Initial firm notification
- Letter
- Center classification date
- Dec 14, 2018