Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Premier Pharmacy Labs Inc: Sterile Injection Syringes Recalled Due to Lack of Sterility Assurance

Agency Publication Date: April 26, 2018
Share:
Sign in to monitor this recall

Summary

Premier Pharmacy Labs Inc. is recalling 12,917 units of various injectable medications, including Morphine Sulfate, Hydromorphone HCl, and Neostigmine Methylsulfate, packaged in sterile single-dose syringes. The recall was initiated because microbial contamination was detected in unreleased product lots, suggesting a potential failure in the sterility of the packaging system. If a non-sterile drug is injected into a patient, it can lead to serious and potentially life-threatening infections. These products were distributed nationwide in the United States and were manufactured at their Weeki Wachee, Florida facility.

Risk

A defect in the interaction between the product syringe and the tamper-evident container closure may allow microorganisms to enter the medication. Injecting a contaminated drug product directly into the body bypasses natural defenses and can cause severe systemic infections or sepsis.

What You Should Do

  1. Check your medication for Morphine Sulfate 2 mg/mL (NDC 69623-129-10) with lot numbers MOR030518IJDSA, MOR030518IJDSB, MOR030518IJDSC, MOR030518IJDSD, or MOR030518IJDSE and a Beyond Use Date (BUD) of 06/03/2018.
  2. Check your medication for Morphine Sulfate 4 mg/mL (NDC 69623-127-10) with lot numbers MOR022318NWDSA, MOR022318NWDSB, MOR022318NWDSC, MOR022318NWDSD, or MOR022318NWDSE and a Beyond Use Date (BUD) of 05/24/2018.
  3. Check your medication for Hydromorphone HCl 1 mg/mL (NDC 69623-249-10) with lot numbers HYD030118IJDSA, HYD030118IJDSB, HYD030118IJDSD, or HYD030118IJDSE and a Beyond Use Date (BUD) of 05/30/2018.
  4. Check your medication for Neostigmine Methylsulfate 1 mg/mL (NDC 69623-234-14) with lot number NEO022218SVDS and a Beyond Use Date (BUD) of 8/21/2018.
  5. Immediately stop using any of the affected products and contact your healthcare provider or pharmacist for guidance on alternative treatments.
  6. Return any unused syringes to the pharmacy or place of purchase for a full refund.
  7. Contact Premier Pharmacy Labs Inc. at 8265 Commercial Way, Weeki Wachee, Florida for further instructions regarding this recall.
  8. Contact the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug Recall Refund Guidance

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

Affected Products

Product: Morphine Sulfate 2 mg/mL PF Injection (1 mL in 3mL syringe)
Model:
NDC 69623-129-10
Lot Numbers:
MOR030518IJDSA (BUD 06/03/2018)
MOR030518IJDSB (BUD 06/03/2018)
MOR030518IJDSC (BUD 06/03/2018)
MOR030518IJDSD (BUD 06/03/2018)
MOR030518IJDSE (BUD 06/03/2018)
Date Ranges: 06/03/2018
Product: Morphine Sulfate 4 mg/mL PF Injection (1 mL in 3mL syringe)
Model:
NDC 69623-127-10
Lot Numbers:
MOR022318NWDSA (BUD 05/24/2018)
MOR022318NWDSB (BUD 05/24/2018)
MOR022318NWDSC (BUD 05/24/2018)
MOR022318NWDSD (BUD 05/24/2018)
MOR022318NWDSE (BUD 05/24/2018)
Date Ranges: 05/24/2018
Product: Hydromorphone HCl 1 mg/mL PF INJ (1mL in 3mL syringe)
Model:
NDC 69623-249-10
Lot Numbers:
HYD030118IJDSA (BUD 05/30/2018)
HYD030118IJDSB (BUD 05/30/2018)
HYD030118IJDSD (BUD 05/30/2018)
HYD030118IJDSE (BUD 05/30/2018)
Date Ranges: 05/30/2018
Product: NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL syringe
Model:
NDC 69623-234-14
Lot Numbers:
NEO022218SVDS (BUD 8/21/2018)
Date Ranges: 08/21/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79803
Status: Resolved
Manufacturer: Premier Pharmacy Labs Inc
Sold By: hospitals; clinics; pharmacies
Manufactured In: United States
Units Affected: 4 products (4555 syringes; 4192 syringes; 3570 syringes; 600 syringes)
Distributed To: Nationwide

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.