Why it was recalled
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Product description
LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
Lot numbers, UPCs & expiration codes
Lot # LAB15G52, LAB11G52, Exp 6/17; LAB18I52, Exp 8/17; LAB9L52, 11/17; LAB1A62, LAB9A62, Exp 12/17
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-0661-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 17, 2017
- FDA report date
- Apr 19, 2017
- Quantity
- 107,940 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0661-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 76732
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot # LAB15G52, LAB11G52, Exp 6/17; LAB18I52, Exp 8/17; LAB9L52, 11/17; LAB1A62, LAB9A62, Exp 12/17
- Postal code
- 60045-4862
- Report date
- Apr 19, 2017
- Product type
- Drugs
- Recall number
- D-0661-2017
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 107,940 bottles
- Termination date
- Jul 9, 2019
- Reason for recall
- Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 17, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 11, 2017