Why it was recalled
Subpotent Drug: concentration of product is less than labeled amount.
Product description
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
Lot numbers, UPCs & expiration codes
Lot: 041306A, Exp 04/19
Where it was sold
Nationwide and Puerto Rico
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-0124-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 21, 2016
- FDA report date
- Nov 9, 2016
- Quantity
- 29,972 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn Inc
Original FDA data
Every field from FDA enforcement report D-0124-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 75418
- Address
- 1925 W Field Ct
- Code information
- Lot: 041306A, Exp 04/19
- Postal code
- 60045-4862
- Report date
- Nov 9, 2016
- Product type
- Drugs
- Recall number
- D-0124-2017
- Classification
- Class II
- Recalling firm
- Akorn Inc
- Product quantity
- 29,972 bottles
- Termination date
- May 10, 2019
- Reason for recall
- Subpotent Drug: concentration of product is less than labeled amount.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Oct 21, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 2, 2016