D-1423-2019 Class II Terminated
FDA drug recall D-1423-2019 was initiated by Premier Pharmacy Labs Inc on June 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 st… The recall status is terminated (terminated October 26, 2021). Affected quantity: 4363 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 3, 2019
- Initiation Date
- June 18, 2019
- Termination Date
- October 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4363 syringes
Product Description
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.
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.