Why it was recalled
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Product description
Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
Lot numbers, UPCs & expiration codes
04042017@34B, 10/01/2017
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-1132-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 23, 2017
- FDA report date
- Sep 13, 2017
- Quantity
- 16 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ImprimisRx CA, Inc., dba ImprimisRx
Original FDA data
Every field from FDA enforcement report D-1132-2017, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 77647
- Address
- 9257 Research Dr
- Code information
- 04042017@34B, 10/01/2017
- Postal code
- 92618-4286
- Report date
- Sep 13, 2017
- Product type
- Drugs
- Recall number
- D-1132-2017
- Classification
- Class II
- Recalling firm
- ImprimisRx CA, Inc., dba ImprimisRx
- Product quantity
- 16 bottles
- Termination date
- Jan 14, 2019
- Reason for recall
- Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 23, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 7, 2017