Why it was recalled
Lack of Processing Controls:
Product description
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
Lot numbers, UPCs & expiration codes
Lots: a) 08012019@33 exp: 8/15/19, 07182019@66 exp: 8/01/19, 07182019@15 exp: 8/01/19, 07012019@46 exp. 08/31/19, 07082019@27 exp: 8/31/19, b) 07082019@55 exp: 8/31/19; 07182019@55 exp: 08/31/19; 06242019@55 exp: 8/31/19; 06202019@16 exp: 8/31/19 c) 08052019@11 exp: 11/3/19
Where it was sold
Product was dispensed to patients
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-1854-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 3, 2019
- FDA report date
- Sep 18, 2019
- Quantity
- a) 6x5ml b) 4x10 c) 1x15 ml bottles,
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Compounded Solutions in Pharmacy
Original FDA data
Every field from FDA enforcement report D-1854-2019, exactly as published.
Show all FDA fields
- City
- Monroe
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 83722
- Address
- 810 Main St
- Code information
- Lots: a) 08012019@33 exp: 8/15/19, 07182019@66 exp: 8/01/19, 07182019@15 exp: 8/01/19, 07012019@46 exp. 08/31/19, 07082019@27 exp: 8/31/19, b) 07082019@55 exp: 8/31/19; 07182019@55 exp: 08/31/19; 06242019@55 exp: 8/31/19; 06202019@16 exp: 8/31/19 c) 08052019@11 exp: 11/3/19
- Postal code
- 06468-2809
- Report date
- Sep 18, 2019
- Product type
- Drugs
- Recall number
- D-1854-2019
- Classification
- Class II
- Recalling firm
- Compounded Solutions in Pharmacy
- Product quantity
- a) 6x5ml b) 4x10 c) 1x15 ml bottles,
- Termination date
- Mar 4, 2020
- Reason for recall
- Lack of Processing Controls:
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
- Distribution pattern
- Product was dispensed to patients
- Recall initiation date
- Sep 3, 2019
- Initial firm notification
- Telephone
- Center classification date
- Sep 12, 2019