Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites* — Class II drug recall D-1423-2019
Terminated recall by Premier Pharmacy Labs Inc, reported 2019-07-03, distributed nationwide. Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross cont
| Recall number | D-1423-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Premier Pharmacy Labs Inc, Weeki Wachee, FL, United States |
| Recall initiated | 2019-06-18 |
| Classified | 2019-06-21 |
| Reported by FDA | 2019-07-03 |
| Terminated | 2021-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 4,363 syringes |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00769623104105 |
| NDC | 69623-0104-10 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1423-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.