Recalls / Class I
Class ID-0299-2019
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
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDC
- 63323-186
- FDA application
- ANDA088912
- Affected lot / code info
- 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
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.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3159 Staley Rd, N/A, Grand Island, New York 14072-2028
Distribution
- Quantity
- 1,312,350 20 mL vials
- Distribution pattern
- Distributed Nationwide in the USA and Puerto RIco
Timeline
- Recall initiated
- 2018-11-15
- FDA classified
- 2018-12-14
- Posted by FDA
- 2018-12-12
- Terminated
- 2023-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0299-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.