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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Premier Pharmacy Labs Inc: Neostigmine Methylsulfate Injection Recalled for Incorrect Expiration Dates

Agency Publication Date: December 21, 2017
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Summary

Premier Pharmacy Labs Inc. is recalling 1,610 syringes of Neostigmine Methylsulfate (1 mg per mL, 5 mg per 5 mL), a compounded injectable medication used in hospital and office settings. The recall was initiated because the product labels show a 'beyond use date' (expiration date) that is longer than what current stability data can support. This means the medication may lose its effectiveness or safety before the date printed on the label. These syringes were distributed to facilities in Florida, Maryland, Michigan, Minnesota, North Carolina, and Ohio.

Risk

Using medication past its true stability date can lead to reduced potency, meaning the drug may not work as intended to reverse the effects of certain muscle relaxants during surgery. While no injuries have been reported, an ineffective dose in a clinical setting could lead to inadequate recovery of muscle function.

What You Should Do

  1. Check your inventory for Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL with NDC# 69623-234-15.
  2. Identify affected units by looking for Lot numbers NEO071317MMDSA, NEO071317MMDSC, or NEO071317MMDSF, all of which list a 'BUD' (Beyond Use Date) of 01/19/2018.
  3. Immediately stop using any syringes from the affected lots and quarantine them to prevent clinical use.
  4. Contact your healthcare provider or pharmacist for guidance regarding the use of this compounded medication.
  5. Return any unused syringes from these lots to the place of purchase for a refund and contact Premier Pharmacy Labs Inc. for further instructions.
  6. For additional questions or to report a complaint, 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

Healthcare provider consultation and pharmacy return

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 (single dose syringe) 1 mg per mL 5 mg per 5 mL
Model:
NDC# 69623-234-15
Recall #: D-0129-2018
Lot Numbers:
NEO071317MMDSA (BUD: 01/19/2018)
NEO071317MMDSC (BUD: 01/19/2018)
NEO071317MMDSF (BUD: 01/19/2018)
Date Ranges: BUD: 01/19/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77979
Status: Resolved
Manufacturer: Premier Pharmacy Labs Inc
Sold By: Hospitals; Medical Offices
Manufactured In: United States
Units Affected: 1610 syringes
Distributed To: Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.