SCA Pharmaceuticals, LLC 2024-04-03 Health serious FDA
Health · FDA · Recall #FDA-D-0411-2024
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only,… Recall
Issued April 3, 2024 · SCA Pharmaceuticals, LLC
In April 2024, SCA Pharmaceuticals, LLC recalled the labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only,…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility
What you should do
- 1 Stop using labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SCA Pharmaceuticals, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SCA Pharmaceuticals, LLC
- Category
- Health
- Recall date
- April 3, 2024
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0411-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- SCA Pharmaceuticals, LLC has 15 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.