Drug product
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.
D-0511-2019
Product summary
- Firm
- Akorn Inc
- Event
- Event 82177
- Status
- Terminated
- Classification
- Class II
- Quantity
- 78120 dropper bottles
- Official record key
drug-enforcement:D-0511-2019
Official wording
Reason: Failed Stability Specification: out of specification results for Sodium Perborate
Code information: Lot # 8D31A, Exp: 03/20; 7H98A, Exp: 07/19; 7L80A, Exp: 10/19.
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
out of specification