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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

US Compounding Inc: Neostigmine Methylsulfate PF Injection Recalled for Missing Labels

Agency Publication Date: December 29, 2020
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Summary

US Compounding Inc has recalled 1,640 units of Neostigmine Methylsulfate PF Injection (5 mg/5 mL) because the syringes were distributed without required labeling. This recall affects single-use syringes intended for hospital or office use only. Without the appropriate label, healthcare providers may not have critical information such as the drug name, concentration, or expiration date, which could lead to medication errors.

Risk

A missing label on a medication syringe creates a high risk of administration error, as the user cannot verify the medication type or dosage before use. Using the wrong drug or an incorrect dose can lead to serious patient harm or lack of expected treatment.

What You Should Do

  1. Identify your supply by checking for Neostigmine Methylsulfate PF Injection, 5 mg/5 mL in 5 mL Single Use Syringes with NDC 62295-3324-05.
  2. Check the specific lot number 20202109 or 20202109@3 with a Beyond Use Date (BUD) of 3/20/2021 to see if your syringes are part of the recall.
  3. Immediately stop using any syringes from the affected lot and quarantine the product to prevent accidental use.
  4. Contact your healthcare provider or pharmacist for guidance, and return any unused or unlabeled syringes to US Compounding Inc for a refund.
  5. Contact US Compounding Inc at (800) 718-3588 for further instructions on returning the product.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Neostigmine Methylsulfate PF Inj. 5 mg/5 mL (5 mL Single Use Syringe)
Model:
NDC 62295-3324-05
Recall #: D-0175-2021
Lot Numbers:
20202109@3 (BUD: 3/20/2021)
20202109
Date Ranges: 3/20/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86929
Status: Resolved
Manufacturer: US Compounding Inc
Sold By: hospitals; medical offices
Manufactured In: United States
Units Affected: 1640 syringes
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.