Why it was recalled
Lack of Process Controls
Product description
ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05
Lot numbers, UPCs & expiration codes
Lot: 06182018@30 Exp. 08/28/2018
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-0090-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 10, 2018
- FDA report date
- Oct 31, 2018
- Quantity
- 222 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Westlab Pharmacy, Inc. dba Westlab Pharmacy
Original FDA data
Every field from FDA enforcement report D-0090-2019, exactly as published.
Show all FDA fields
- City
- Gainesville
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 80838
- Address
- 4410 W Newberry Rd Ste A5
- Code information
- Lot: 06182018@30 Exp. 08/28/2018
- Postal code
- 32607-2290
- Report date
- Oct 31, 2018
- Product type
- Drugs
- Recall number
- D-0090-2019
- Classification
- Class II
- Recalling firm
- Westlab Pharmacy, Inc. dba Westlab Pharmacy
- Product quantity
- 222 syringes
- Termination date
- May 7, 2020
- Reason for recall
- Lack of Process Controls
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 10, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2018