Why it was recalled
Lack of Assurance of Sterility
Product description
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Lot numbers, UPCs & expiration codes
Lots: 03012021@35; 04132021@10; 05102021@12; 06012021@28; 07012021@25; 03012021@36; 04132021@12; 05102021@11; 06012021@29; 07132021@14; 03152021@9; 06162021@21; 07132021@16; 03152021@10; 06162021@22
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-0804-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 18, 2021
- FDA report date
- Sep 22, 2021
- Quantity
- 350 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prescription Labs Inc dba Greenpark
Original FDA data
Every field from FDA enforcement report D-0804-2021, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 88515
- Address
- 4061f Bellaire Blvd
- Code information
- Lots: 03012021@35; 04132021@10; 05102021@12; 06012021@28; 07012021@25; 03012021@36; 04132021@12; 05102021@11; 06012021@29; 07132021@14; 03152021@9; 06162021@21; 07132021@16; 03152021@10; 06162021@22
- Postal code
- 77025-1121
- Report date
- Sep 22, 2021
- Product type
- Drugs
- Recall number
- D-0804-2021
- Classification
- Class II
- Recalling firm
- Prescription Labs Inc dba Greenpark
- Product quantity
- 350 bottles
- Termination date
- Aug 15, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 18, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 16, 2021