Why it was recalled
Failed Stability Specification: out of specification results for Sodium Perborate
Product description
Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.
Lot numbers, UPCs & expiration codes
Lot # 8D31A, Exp: 03/20; 7H98A, Exp: 07/19; 7L80A, Exp: 10/19.
Where it was sold
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-0511-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 4, 2019
- FDA report date
- Feb 27, 2019
- Quantity
- 78120 dropper bottles
- Recalling firm
- Akorn Inc
Original FDA data
Every field from FDA enforcement report D-0511-2019, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 82177
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot # 8D31A, Exp: 03/20; 7H98A, Exp: 07/19; 7L80A, Exp: 10/19.
- Postal code
- 60045-4862
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0511-2019
- Classification
- Class II
- Recalling firm
- Akorn Inc
- Product quantity
- 78120 dropper bottles
- Termination date
- Jul 29, 2022
- Reason for recall
- Failed Stability Specification: out of specification results for Sodium Perborate
- Product description
- Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 4, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 19, 2019