Why it was recalled
Lack of sterility assurance.
Product description
Cyclosporin liquid 0.2%, Rx, plastic dropper bottle
Lot numbers, UPCs & expiration codes
10042018@10
Where it was sold
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 - specific to each patient. Firm did not provide labeling.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0405-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 2, 2019
- FDA report date
- Jan 9, 2019
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-0405-2019, exactly as published.
Show all FDA fields
- City
- Roseburg
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 81883
- Address
- 1350 Ne Stephens St Ste 42
- Code information
- 10042018@10
- Postal code
- 97470-6410
- Report date
- Jan 9, 2019
- Product type
- Drugs
- Recall number
- D-0405-2019
- Classification
- Class II
- Recalling firm
- Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
- Termination date
- Mar 28, 2023
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cyclosporin liquid 0.2%, Rx, plastic dropper bottle
- Distribution pattern
- 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 - specific to each patient. Firm did not provide labeling.
- Recall initiation date
- Jan 2, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 27, 2019