Why it was recalled
Lack of sterility assurance.
Product description
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
Lot numbers, UPCs & expiration codes
Lot: 11072018@10 BUD: 12/22/2018
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-0431-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 17, 2018
- FDA report date
- Feb 20, 2019
- Quantity
- 75 10 ml bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Promise Pharmacy, LLC
Original FDA data
Every field from FDA enforcement report D-0431-2019, exactly as published.
Show all FDA fields
- City
- Palm Harbor
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 81810
- Address
- 31818 Us Highway 19 N
- Code information
- Lot: 11072018@10 BUD: 12/22/2018
- Postal code
- 34684-3713
- Report date
- Feb 20, 2019
- Product type
- Drugs
- Recall number
- D-0431-2019
- Classification
- Class II
- Recalling firm
- Promise Pharmacy, LLC
- Product quantity
- 75 10 ml bottles
- Termination date
- Mar 30, 2021
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Dec 17, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2019