Why it was recalled
Failed Impurities/Degradation Specifications.
Product description
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..
Lot numbers, UPCs & expiration codes
Lot #: a) 94659 Exp. FEB-2019; b) 94715, Exp. JAN-2019; 94757, Exp. FEB-2019, 94715A, Exp. JAN-2019; 95297, Exp. MAR-2019; c) 95223 Exp. MAR-2019; d) 95220 Exp. MAR-2019
Where it was sold
Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
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-0077-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 19, 2017
- FDA report date
- Nov 22, 2017
- Quantity
- 715,041 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allergan Sales, LLC
Original FDA data
Every field from FDA enforcement report D-0077-2018, exactly as published.
Show all FDA fields
- City
- Waco
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 78325
- Address
- 8301 Mars Dr
- Code information
- Lot #: a) 94659 Exp. FEB-2019; b) 94715, Exp. JAN-2019; 94757, Exp. FEB-2019, 94715A, Exp. JAN-2019; 95297, Exp. MAR-2019; c) 95223 Exp. MAR-2019; d) 95220 Exp. MAR-2019
- Postal code
- 76712-6578
- Report date
- Nov 22, 2017
- Product type
- Drugs
- Recall number
- D-0077-2018
- Classification
- Class III
- Recalling firm
- Allergan Sales, LLC
- Product quantity
- 715,041 bottles
- Termination date
- Oct 30, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..
- Distribution pattern
- Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
- Recall initiation date
- Oct 19, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 13, 2017