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Drug recall · FDA · Published April 11, 2018

Premier Pharmacy Labs Inc recalls NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way

Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

🇺🇸 FDA recall #D-0702-2018DrugPremier Pharmacy Labs Inc ›
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Recalling firmPremier Pharmacy Labs Inc8265 Commercial Way, N/A · Weeki Wachee, FL 34613-4511
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.

Source Page by GovInfoNow · govinfonow.com/recall/40618-premier-pharmacy-labs-inc-recalls-neostigmine-methylsulfate-1-mg-ml · Recall date April 11, 2018 · FDA enforcement record: FDA #D-0702-2018

Cite this page

“Premier Pharmacy Labs Inc recalls NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way.” GovInfoNow, recall dated April 11, 2018. https://govinfonow.com/recall/40618-premier-pharmacy-labs-inc-recalls-neostigmine-methylsulfate-1-mg-ml. Based on FDA recall #D-0702-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0702-2018%22&limit=1).

How to tell if you have this one

  • Brand
    Premier Pharmacy Labs Inc
  • Category
    Drug
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide in the USA
Recall numberProduct, codes & lotsQuantity
D-0699-2018Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10; Lots: MOR030518IJDSA, MOR030518IJDSB, MOR030518IJDSC, MOR030518IJDSD, MOR030518IJDSE BUD: 06/03/2018;4555 syringes
D-0700-2018Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10; Lots: MOR022318NWDSA, MOR022318NWDSB, MOR022318NWDSC, MOR022318NWDSD, MOR022318NWDSE BUD: 05/24/20184192 syringes
D-0701-2018Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10; Lots: HYD030118IJDSA, HYD030118IJDSB, HYD030118IJDSD, HYD030118IJDSE BUD: 05/30/20183570 syringes
D-0702-2018NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14.; Lot: NEO022218SVDS BUD: 8/21/2018600 syringes
Take action

Contact Premier Pharmacy Labs Inc

We’ve drafted a message you can send Premier Pharmacy Labs Inc to request your refund or repair — edit it as you like.

Subject: Recall D-0702-2018 — Premier Pharmacy Labs Inc Premier Pharmacy Labs Inc recalls NEOstigmine Methylsulfate (1 mg/mL) 3mg

Hello,

I own a Premier Pharmacy Labs Inc recalls NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way that is covered by recall D-0702-2018 from Premier Pharmacy Labs Inc.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0702-2018 (April 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0702-2018 to see it in context.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA