D-1415-2019 Class II Terminated
FDA drug recall D-1415-2019 was initiated by Premier Pharmacy Labs Inc on Jun 18, 2019 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Oct 26, 2021). Affected quantity: 2315 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 3, 2019
- Initiation Date
- Jun 18, 2019
- Termination Date
- Oct 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2315 syringes
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA
Code Information
All lots remaining within expiry.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1415-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026