Pfizer Inc. 2024-07-03 Health serious FDA
Health · FDA · Recall #FDA-D-0565-2024
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject,… Recall
Issued July 3, 2024 · Pfizer Inc.
In July 2024, Pfizer Inc. recalled the Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
What you should do
- 1 Stop using Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Pfizer Inc. 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
- Pfizer Inc.
- Category
- Health
- Recall date
- July 3, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide and Puerto Rico.
- Recall number
- FDA-D-0565-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Pfizer Inc. has 13 recalls in our database, including 5 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.