D-1388-2020 Class III Terminated
FDA drug recall D-1388-2020 was initiated by Akorn, Inc. on December 26, 2019 and is designated Class III. Reason for recall: Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample The recall status is terminated (terminated July 28, 2022). Affected quantity: 33,343 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 22, 2020
- Initiation Date
- December 26, 2019
- Termination Date
- July 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,343 bottles
Product Description
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
Reason for Recall
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Lot 9E52A, exp 04/2021