Why it was recalled
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Product description
Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
Nationwide
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-864-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 25, 2013
- FDA report date
- Aug 21, 2013
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pallimed Solutions
Original FDA data
Every field from FDA enforcement report D-864-2013, exactly as published.
Show all FDA fields
- City
- Woburn
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 64716
- Address
- 400 W Cummings Park
- Code information
- All lots within expiry
- Postal code
- 01801-6519
- Report date
- Aug 21, 2013
- Product type
- Drugs
- Recall number
- D-864-2013
- Classification
- Class II
- Recalling firm
- Pallimed Solutions
- Termination date
- Aug 21, 2013
- Reason for recall
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 25, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 9, 2013