Premier Pharmacy Labs Inc recalls Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy
Premier Pharmacy recalls Droperidol Injectable Sterile Solution due to potential contamination risks from inadequate sterilization processes. Affected products include specific lot numbers and sizes. Contact for details.
Recall notice
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Contact the company & request your remedy
What happened, in plain English
Premier Pharmacy is recalling Droperidol Injectable Sterile Solution products because FDA inspections found insufficient environmental controls that could lead to contamination. This recall affects patients receiving the medication under prescription. Read more at govinfonow.com/recall/38617-premier-pharmacy-droperidol-injectables-recall-risk-of-contaminated-product.
Source Summary by GovInfoNow · govinfonow.com/recall/38617-premier-pharmacy-droperidol-injectables-recall-risk-of-contaminated-product · Updated October 5, 2026 · FDA enforcement record: FDA #D-1415-2019
Cite this page
“Premier Pharmacy Droperidol Injectables Recall: Risk of Contaminated Product.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38617-premier-pharmacy-droperidol-injectables-recall-risk-of-contaminated-product. Based on FDA recall #D-1415-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1415-2019%22&limit=1).
Why it’s dangerous
FDA inspections found that the manufacturing environment lacked proper controls, which could lead to cross-contamination and insufficient sterility assurance. This risk means the product might not be sterile, potentially causing infections or other health issues.
Who’s affected
Patients prescribed Droper: 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe by Premier Pharmacy. Healthcare providers administering the medication are most at risk.
How to tell if you have this one
Check for the product name 'Droperidol Injectable Sterile Solution', 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, and the NDC code 69623-185-10. The product was sold by Premier Pharmacy Labs in Florida.
- Brand
Premier Pharmacy- Product
Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy- Category
Drug
All 18 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 number | Product, codes & lots | Quantity |
|---|---|---|
| D-1411-2019 | Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-131-12, barcode 0 69623 13112 6.; All lots remaining within expiry. | 745 syringes |
| D-1412-2019 | Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-211-31, barcode 2 69623 21131 0.; All lots remaining within expiry. | 578 vials |
| D-1413-2019 | ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4.; All lots remaining within expiry. | 824 vials |
| D-1414-2019 | Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-252-10, barcode 0 69623 25210 4.; All lots remaining within expiry. | 86 syringes |
| D-1415-2019 | Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-185-10, barcode 0 69623 18510 5.; All lots remaining within expiry. | 2315 syringes |
| D-1416-2019 | Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-230-57, barcode 0 69623 23057 7.; All lots remaining within expiry. | 606 bags |
| D-1417-2019 | Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-240-57, barcode 0 69623 24057 7.; All lots remaining within expiry. | 1235 bags |
| D-1418-2019 | Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-107-57, barcode 3 69623 10757 3.; All lots remaining within expiry. | 40 bags |
| D-1419-2019 | Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-176-31, barcode 6 69623 17631 0.; All lots remaining within expiry. | 323 vials |
| D-1420-2019 | Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35, barcode 5 69623 16035 0.; All lots remaining within expiry. | 1834 irrigation vials |
| D-1421-2019 | Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-235-39, barcode 6 69623 23539 0.; All lots remaining within expiry. | 6 vials |
| D-1422-2019 | Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-234-15, barcode 5 69623 23415 0.; All lots remaining within expiry. | 4806 syringes |
| D-1423-2019 | Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-104-10, barcode 7 69623 10410 5.; All lots remaining within expiry. | 4363 syringes |
| D-1424-2019 | Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-236-16, barcode 8 69623 23616 2.; All lots remaining within expiry. | 1040 syringes |
| D-1425-2019 | Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9.; All lots remaining within expiry. | 125 dropper bottles |
| D-1426-2019 | Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-232-39, barcode 8 69623 23239 3.; All lots remaining within expiry. | 13150 vials |
| D-1427-2019 | SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-15, barcode 0 69623 23915 0.; All lots remaining within expiry. | 6423 syringes |
| D-1428-2019 | SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-16, barcode 9 69623 23916 0.; All lots remaining within expiry. | 1721 syringes |
What to do — step by step
Check Product Details
Verify the product name, size, and NDC code to confirm if it matches the recalled items.
Questions people ask
Is this product safe to use?
The FDA found potential contamination risks, so the product is not safe to use as recalled. Contact Premier Pharmacy for specific guidance.
What should I do if I have this product?
The recall does not specify a remedy, so contact Premier Pharmacy directly for instructions.
How can I check if my product is affected?
Look for the NDC code 69623-185-10 and the product description mentioned in the recall notice.
Contact Premier Pharmacy
We’ve drafted a message you can send Premier Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-1415-2019 — Premier Pharmacy Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Us Hello, I own a Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy that is covered by recall D-1415-2019 from Premier Pharmacy. 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-1415-2019 (June 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1415-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- 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.