Why it was recalled
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Product description
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38
Lot numbers, UPCs & expiration codes
All unexpired lots; a) Expirations dates of 10/03/2016 to 11/06/2016 and b) 09/25/2016 to 10/01/2016
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-0013-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 20, 2016
- FDA report date
- Oct 19, 2016
- Quantity
- 76,315 total units, all products
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Leiter's Compounding
Original FDA data
Every field from FDA enforcement report D-0013-2017, exactly as published.
Show all FDA fields
- City
- San Jose
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 75230
- Address
- 17 Great Oaks Blvd
- Code information
- All unexpired lots; a) Expirations dates of 10/03/2016 to 11/06/2016 and b) 09/25/2016 to 10/01/2016
- Postal code
- 95119-1359
- Report date
- Oct 19, 2016
- Product type
- Drugs
- Recall number
- D-0013-2017
- Classification
- Class II
- Recalling firm
- Leiter's Compounding
- Product quantity
- 76,315 total units, all products
- Termination date
- May 3, 2017
- Reason for recall
- Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 20, 2016
- Initial firm notification
- Letter
- Center classification date
- Oct 12, 2016