D-0511-2019 Class II Terminated
FDA drug recall D-0511-2019 was initiated by Akorn Inc on February 4, 2019 and is designated Class II. Reason for recall: Failed Stability Specification: out of specification results for Sodium Perborate The recall status is terminated (terminated July 29, 2022). Affected quantity: 78120 dropper bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 27, 2019
- Initiation Date
- February 4, 2019
- Termination Date
- July 29, 2022
- Voluntary/Mandated
- Product Quantity
- 78120 dropper bottles
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.
Reason for Recall
Failed Stability Specification: out of specification results for Sodium Perborate
Distribution Pattern
Nationwide in the USA.
Code Information
Lot # 8D31A, Exp: 03/20; 7H98A, Exp: 07/19; 7L80A, Exp: 10/19.