Why it was recalled
Subpotent Drug
Product description
Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
Lot numbers, UPCs & expiration codes
Lot #:01252019@1, Exp. 07/21/2019; 03182019@7, Exp. 09/7/2019; 05092019@2, Exp. 11/2/2019
Where it was sold
Nationwide within the United States
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-1578-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 17, 2019
- FDA report date
- Aug 7, 2019
- Quantity
- 405 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ImprimisRx NJ
Original FDA data
Every field from FDA enforcement report D-1578-2019, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83353
- Address
- 1705 Us Highway 46 Ste 4
- Code information
- Lot #:01252019@1, Exp. 07/21/2019; 03182019@7, Exp. 09/7/2019; 05092019@2, Exp. 11/2/2019
- Postal code
- 07852-9720
- Report date
- Aug 7, 2019
- Product type
- Drugs
- Recall number
- D-1578-2019
- Classification
- Class II
- Recalling firm
- ImprimisRx NJ
- Product quantity
- 405 bottles
- Termination date
- Apr 22, 2020
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 17, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 31, 2019