Why it was recalled
cGMP Deviations
Product description
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05
Lot numbers, UPCs & expiration codes
Lot#: 99946 Exp. January 16, 2021
Where it was sold
TN only
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-1056-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 19, 2019
- FDA report date
- Apr 3, 2019
- Quantity
- 72 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allergan Sales, LLC
Original FDA data
Every field from FDA enforcement report D-1056-2019, exactly as published.
Show all FDA fields
- City
- Waco
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 82424
- Address
- 8301 Mars Dr
- Code information
- Lot#: 99946 Exp. January 16, 2021
- Postal code
- 76712-6578
- Report date
- Apr 3, 2019
- Product type
- Drugs
- Recall number
- D-1056-2019
- Classification
- Class II
- Recalling firm
- Allergan Sales, LLC
- Product quantity
- 72 bottles
- Termination date
- Apr 29, 2020
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05
- Distribution pattern
- TN only
- Recall initiation date
- Mar 19, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 22, 2019