Drug recall: Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye
Class II FDA enforcement event 81883. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of sterility assurance.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy started this drug recall on 2 Jan 2019. The firm address in the FDA record is in Roseburg, OR. FDA put the recall in Class II. FDA event 81883 has 17 product records. The first FDA enforcement report date is 9 Jan 2019. The record gives the status Terminated, with the termination date 28 Mar 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound -…
Recalling firm
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy, Roseburg, OR.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
17 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0392-2019 | Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye | 830 ml | Class II | Terminated | 9 Jan 2019 |
| D-0393-2019 | Epinephrine liquid 1:1000, RX, glass vial | 50 ml | Class II | Terminated | 9 Jan 2019 |
| D-0394-2019 | Glutathione liquid, 100mg/ml | 60 ml | Class II | Terminated | 9 Jan 2019 |
| D-0395-2019 | HCG liquid, 1000u/ml, RX, glass vial, various | 30 ml | Class II | Terminated | 9 Jan 2019 |
| D-0396-2019 | Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial | 20 ml | Class II | Terminated | 9 Jan 2019 |
| D-0397-2019 | Lidocaine gel 2%, RX, plastic dropper | 125 ml | Class II | Terminated | 9 Jan 2019 |
| D-0398-2019 | Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments | 50 ml | Class II | Terminated | 9 Jan 2019 |
| D-0399-2019 | MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial | 310 ml | Class II | Terminated | 9 Jan 2019 |
| D-0400-2019 | Methocarbamol liquid 100mg/ml, RX, glass vial | 300 ml | Class II | Terminated | 9 Jan 2019 |
| D-0401-2019 | Testosteron Cypionate liquid 200mg/ml, RX, glass vial | 200 ml | Class II | Terminated | 9 Jan 2019 |
| D-0402-2019 | Vitamin B12 liquid 1000mcg/ml, RX, glass vial | 150 ml | Class II | Terminated | 9 Jan 2019 |
| D-0403-2019 | Cyclosporin liquid 1%, Rx, plastic dropper bottle | N/A | Class II | Terminated | 9 Jan 2019 |
| D-0404-2019 | Cyclosporin liquid 0.5%, Rx, plastic dropper bottle | N/A | Class II | Terminated | 9 Jan 2019 |
| D-0405-2019 | Cyclosporin liquid 0.2%, Rx, plastic dropper bottle | N/A | Class II | Terminated | 9 Jan 2019 |
| D-0406-2019 | Cyclosporin liquid 0.05%, Rx, plastic dropper bottle | N/A | Class II | Terminated | 9 Jan 2019 |
| D-0407-2019 | Glutathione liquid, 200mg/ml, Rx | N/A | Class II | Terminated | 9 Jan 2019 |
| D-0408-2019 | Lidocaine gel 1%, RX, plastic dropper | N/A | Class II | Terminated | 9 Jan 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2019
- 362
- Share of these events in Class II
- 68%
- Product records in this event
- 17
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-0392-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 81883. https://recallregister.com/fda/ii/81883/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound -…
- What quantity of product is in FDA event 81883?
- The event has 17 product records. The first record gives this quantity:
830 ml
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2019 have the same class?
- 68% of the 362 drug events that started in 2019 are in Class II.