Why it was recalled
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Product description
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
Lot numbers, UPCs & expiration codes
Lot 0B61A, Exp 01/31/2022
Where it was sold
Distributed 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-0004-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 4, 2021
- FDA report date
- Oct 13, 2021
- Quantity
- 10,210 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0004-2022, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 88823
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot 0B61A, Exp 01/31/2022
- Postal code
- 60045-4862
- Report date
- Oct 13, 2021
- Product type
- Drugs
- Recall number
- D-0004-2022
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 10,210 bottles
- Termination date
- Aug 17, 2022
- Reason for recall
- Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Oct 4, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 7, 2021