CLASS II Drug recall · Reported 3 Jul 2019 · FDA Enforcement Report
Orphenadrine Citrate Sterile Injectable Solution *Contains recalled
Premier Pharmacy Labs is recalling Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL Sterile, distributed nationwide in the US. The recall was initiated on 18 Jun 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1423-2019
- FDA event ID
- 83146
- Recalling firm
- Premier Pharmacy Labs, Weeki Wachee, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jun 2019
- FDA classified
- 21 Jun 2019
- Reported
- 3 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Jun 2019 | Recall initiated by company | |
| 21 Jun 2019 | Classified by FDA | +3 days |
| 3 Jul 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
17 other products · FDA event 83146This product is part of a recall event; the main page for the event is Droperidol Injectable Sterile Solution, 0.625mg/mL recalled.
More recalls from Premier Pharmacy Labs
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naloxone HCL Preserved INJ, 500mg/ (10mg/mL) Sterile MDV recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Mitomycin Preservative Free Irrigation, 40mg/ (4mg/mL) SDV recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg recalled | Premier Pharmacy Labs | Sterility | Nationwide |