Nephron Sterile Compounding Center LLC 2022-08-24 Health serious FDA
Health · FDA · Recall #FDA-D-1344-2022
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose… Recall
Issued August 24, 2022 · Nephron Sterile Compounding Center LLC
In August 2022, Nephron Sterile Compounding Center LLC recalled the PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose…, 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
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
What you should do
- 1 Stop using PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Nephron Sterile Compounding Center 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
- Nephron Sterile Compounding Center LLC
- Category
- Health
- Recall date
- August 24, 2022
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-1344-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Nephron Sterile Compounding Center LLC has 29 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.