D-0835-2016 Class II Terminated
FDA drug recall D-0835-2016 was initiated by Akorn, Inc. on Apr 7, 2016 and is designated Class II. Reason for recall: Presence of Particulate Matter The recall status is terminated (terminated Sep 13, 2016). Affected quantity: 10,060 bottles (Good Neighbor Pharmacy: 6,731 bottles/Premier Value Brand: 3,323 bottles).
Recall Details
- Product Type
- Drugs
- Report Date
- May 11, 2016
- Initiation Date
- Apr 7, 2016
- Termination Date
- Sep 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,060 bottles (Good Neighbor Pharmacy: 6,731 bottles/Premier Value Brand: 3,323 bottles)
Product Description
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-0404-00.
Reason for Recall
Presence of Particulate Matter
Distribution Pattern
Nationwide
Code Information
Good Neighbor Pharmacy Batch Number 4H76A; Exp 07/16 Premier Value Batch Number 4H76B; Exp 07/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0835-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026