Why it was recalled
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Product description
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Lot numbers, UPCs & expiration codes
Lot # 06272022@3, Exp. date 11/24/2022 Lot # 08302022@1, Exp. date 01/27/2023
Where it was sold
Nationwide in the USA
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-0060-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 9, 2022
- FDA report date
- Nov 23, 2022
- Quantity
- 960 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ImprimisRx NJ
Original FDA data
Every field from FDA enforcement report D-0060-2023, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91140
- Address
- 1705 Us Highway 46 Ste 4
- Code information
- Lot # 06272022@3, Exp. date 11/24/2022 Lot # 08302022@1, Exp. date 01/27/2023
- Postal code
- 07852-9720
- Report date
- Nov 23, 2022
- Product type
- Drugs
- Recall number
- D-0060-2023
- Classification
- Class II
- Recalling firm
- ImprimisRx NJ
- Product quantity
- 960 bottles
- Termination date
- Aug 23, 2023
- Reason for recall
- Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 9, 2022
- Initial firm notification
- Letter
- Center classification date
- Nov 14, 2022